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Diabetic Foot Ulcers and Their Recurrence
Abstract
Lower-extremity complications of diabetes such as foot ulcers constitute a substantial burden for people with diabetes. Once healed, foot ulcers frequently recur. This fact, coupled with demographic trends, requires a collective refocusing on prevention and a reallocation of resources from simply healing active ulcers to maximizing ulcer-free days for all patients with a history of diabetic foot ulceration. Aggressive therapy during active disease combined with a focus on improving care during remission can lead to more ulcer-free days, fewer inpatient and outpatient visits, and an improved quality of life.
... Worldwide 463 million people are living with diabetes mellitus (DM) and this number is expected to rise to 700 million by 2045. 1 Diabetic foot ulcer (DFU), as one of the most severe diabetic complications of the lower extremities, will be developed in up to 34 % of persons with diabetes during their lifetime. 2 Amputation, as the most serious complication of diabetes in the lower extremities, takes place every 20 seconds somewhere in the world. 3 In the United States, health ...
... care costs for people with diagnosed diabetes accounts for one-quarter of the total health care costs and more than half of that is directly related to diabetes. 4 More than a third of the cost of diabetes treatment is lower-extremity-related. 2 Although the data on the burden of diabetes foot disease are obvious, this complication is underestimated in scientific and clinical practice compared to other DM complications. 5 DFU usually develops as a result of several risk factors present in people with diabetes, with diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD) usually playing a central role in this process. DPN causes loss of protective sensation (LOPS), increases the skin susceptibility to cracking, can sometimes lead to deformities of the foot which often result in abnormal foot loading. ...
Background/Aim: Preventing lower limb diabetic complications begins with identifying those at risk for diabetic foot ulceration (DFU). DFU development is related to abnormal pattern of plantar pressure distribution caused by alterations in foot rollover process due to loss of foot-ankle muscular strength, impaired range of motion (ROM) and nervous function, as their integrity is needed to enable proper load absorption on plantar surface. Objective of study was to determine correlation between biomechanical parameters of lower limb: ankle and foot muscle strength, ROM at ankle joint (AJ), subtalar joint (SJ) and first metatarsophalangeal joint (I MTP) and overall risk for DFU assessed by IWGDF 2019 Guidance risk stratification system. Methods: A cross-sectional study included 100 diabetic patients, both types. Patients were classified into 4 DFU risk categories applying IWGDF Guidelines 2019 stratification risk system. Function of ten foot and ankle muscles was evaluated by manual muscle testing applying Michigan Diabetic Neuropathy Score system and was expressed by muscle score (MS) on dominant leg. ROM at AJ, SJ and I MTP was measured with a goniometer on dominant leg and was expressed by degree (°). Results: Average MS in specified categories were as follows: Category 0: 9.2; Category 1: 13.9; Category 2: 13.3; Category 3: 15.2 and they were significantly different. Average ROM at AJ in specified categories were as follows: Category 0: 49.3°; Category 1: 48.8°; Category 2: 45.5°; Category 3: 44.6° and they were not significantly different. Average ROM at SJ in specified categories were as follows: Category 0: 37.8°; Category 1: 31.3°; Category 2: 35.0°; Category 3: 28.7° and they were significantly different. Average ROM at I MTP in specified categories were as follows: Category 0: 78.60 ; Category 1: 74.4°; Category 2: 65.5°; Category 3: 57.9° and they were significantly different. Conclusions: Risk for DFU ulcer significantly correlates with decreased ankle and foot muscle strength and ROM at SJ and I MTP but does not correlate with ROM at AJ.
... As úlceras nos pés são uma complicação comum do Diabetes Mellitus (DM), formando-se como resultado de alterações mecânicas na arquitetura óssea do pé, neuropatia periférica e doença aterosclerótica periférica (1) . Caracterizam-se pela quebra do tecido cutâneo e exposição das camadas subjacentes a pele. ...
... Estão associadas à osteomielite, amputações de membros inferiores e aumento significativo da mortalidade (2) . Estima-se que uma em cada quatro pessoas com DM desenvolverá uma úlcera no pé durante a vida (1) . Setenta por cento dessas úlceras permanecem sem cicatrização após 20 semanas de tratamento e 60% progridem para infecção, das quais 20% resultam em diferentes níveis de amputação (3) . ...
Objetivo: analisar a qualidade de vida de pessoas com úlceras do pé diabético em tratamento ambulatorial. Método: estudo descritivo e transversal, realizado entre fevereiro e abril de 2019, com 50 pessoas com Diabetes Mellitus, acompanhados em ambulatório especializado. Foram aplicados o questionário sociodemográfico e clínico, o instrumento Freiburg Life Quality Assessment Wound Versão Feridas (FLQA-WK), estatística descritiva e os testes de Comparação t de Student e Anova. Resultados: observou-se menor escore no domínio sintomas físicos (1.84) e maior no domínio vida diária (3.52). O escore total de qualidade de vida foi de 2.61, numa escala que varia de um a cinco, com correlação significativa entre as variáveis clínicas, como tempo de diagnóstico de diabetes >10 anos (p-valor=0,005), internações hospitalares (p valor=0,019) e nefropatia (p-valor=0,001). Conclusão: a qualidade de vida foi considerada regular, com alteração no domínio vida diária, sendo influenciada negativamente por variáveis clínicas. Descritores: Pé Diabético. Qualidade de Vida. Diabetes Mellitus. Assistência Ambulatorial. Enfermagem.
... And once they occur, there is a high recurrence rate within 3-5 years (65%). Moreover, DFUs result in a 20% incidence of lifetime lower limb amputation, with a 5-year mortality rate after amputation ranging from 50% to 70% (4). ...
... Neuropathic foot ulcers arise due to multiple factors, such as peripheral neuropathy, peripheral arterial disease, and structural deformities in the foot. However, elevated plantar pressure plays a crucial role in initiating neuropathic foot ulcers, particularly in the absence of protective sensation (4,7). Moreover, effective unloading of the affected area is crucial for timely wound healing, as the presence of a neuropathic ulcer can cause significant delays. ...
Objective
This study aimed to evaluate the effectiveness of total contact casts (TCCs) versus removable offloading interventions among patients with diabetic foot ulcers (DFUs).
Methods
A comprehensive search was done in databases Embase, Cochrane Library, and, PubMed. The references of retrieved articles were reviewed, up until February 2023. Controlled trials comparing the effects of TCCs with removable offloading interventions (removable walking casts and footwear) in patients with DFUs were eligible for review.
Results
Twelve studies were included in the meta-analysis, involving 591 patients with DFUs. Among them, 269 patients were in the intervention group (TCC), and 322 in the control group (removable walking casts/footwear). The analysis revealed that the TCC group had higher healing rates (Risk Ratio(RR)=1.22; 95% confidence interval(CI):1.11 to 1.34, p<0.001), shorter healing time (Standard Mean Difference(SMD)=-0.57; 95%CI: -1.01 to -0.13, P=0.010), and elevated occurrence of device-related complications (RR=1.70; 95%CI:1.01 to 2.88, P=0.047), compared with the control group. Subgroup analysis illustrated patients using TCCs had higher healing rates than those using removable walking casts (RR=1.20; 95%CI:1.08 to 1.34, p=0.001) and footwear (RR=1.25; 95%CI:1.04 to 1.51, p=0.019), but they required comparable time for ulcer healing compared with those using removable walking casts (SMD=-0.60; 95%CI: -1.22 to 0.02, P=0.058) or footwear group (SMD=-0.52; 95%CI: -1.17 to 0.12, P=0.110). Although patients using TCCs had significantly higher incidence of device-related complications than those using footwear (RR=4.81; 95%CI:1.30 to 17.74, p=0.018), they had similar one compared with those using the removable walking casts (RR=1.27; 95%CI:0.70 to 2.29, p=0.438).
Conclusion
The use of TCCs in patients with DFUs resulted in improved rates of ulcer healing and shorter healing time compared to removable walking casts and footwear. However, it is important to note that TCCs were found to be associated with increased prevalence of complications.
... 23 Among people living with diabetes, it has been estimated that one-third develop a diabetic foot ulcer, and more than one-sixth experience a diabetic foot infection (DFI). 4 Currently, there is no consensus on the optimal management of DFI and diabetic foot osteomyelitis (DFO), and approximately 20% of patients end up requiring an amputation. 4 In recent years, alternatives to amputation procedures have been proposed in selected patient subgroups-antibiotic therapy alone 1,2,9,16,25,27 and conservative surgery (synonyms: internal resection, internal partial foot amputation 24 ). ...
... 4 Currently, there is no consensus on the optimal management of DFI and diabetic foot osteomyelitis (DFO), and approximately 20% of patients end up requiring an amputation. 4 In recent years, alternatives to amputation procedures have been proposed in selected patient subgroups-antibiotic therapy alone 1,2,9,16,25,27 and conservative surgery (synonyms: internal resection, internal partial foot amputation 24 ). The latter involves removal of infected bone and nonviable soft tissue, without amputation. ...
Background
There is uncertainty regarding the optimal surgical intervention for diabetic foot osteomyelitis (DFO). Conservative surgery—amputation-free resection of infected bone and soft tissues—is gaining traction as an alternative to minor amputation. Our primary objective was to explore the comparative effectiveness of conservative surgery and minor amputations in clinical failure risk 1 year after index intervention. We also aimed to explore microbiological recurrence at 1 year, and revision surgery risk over a 10-year study period.
Methods
Retrospective, single-center chart review of DFO patients undergoing either conservative surgery or minor amputation. We used multivariable Cox regression and Kaplan-Meier estimates to explore the effect of surgical intervention on clinical failure (recurrent diabetic foot infection at surgical site within 1 year after index operation), microbiological recurrence at 1 year, and revision surgery risk over a 10-year follow-up period.
Results
651 patients were included (conservative surgery, n = 121; minor amputation, n = 530). Clinical failure occurred in 34 (28%) patients in the conservative surgery group, and in 111 (21%) of the minor amputation group at 1 year ( P = .09). After controlling for potential confounders, we found no association between conservative surgery and clinical failure at 1 year (adjusted hazard ratio [HR] 1.3, 95% CI 0.8-2.1). We found no between-group differences in microbiological recurrence at 1 year (conservative surgery: 8 [6.6%]; minor amputation: 33 [6.2%]; P = .25; adjusted HR 1.1, 95% CI 0.5-2.6). Over the 10-year period, the conservative group underwent significantly more revision surgeries (conservative surgery: 85 [70.2%]; minor amputation: 252 [47.5%]; P < .01; adjusted HR 1.3, 95% CI 0.9-1.8).
Conclusion
We found that with comorbidity-based patient selection, conservative surgery in the treatment of DFO was associated with the same rates of clinical failure and microbiological recurrence at 1 year, but with significantly more revision surgeries during follow-up, compared with minor amputations.
Level of Evidence
Level III, retrospective comparative effectiveness study.
... As one of the most severe complications of diabetes, diabetic foot ulcers (DFU) belong to lower extremity vascular disease accompanied by a major risk of infection amputation, and death [1,2]. At present, DFU is becoming a worldwide public health challenge, threatening 9.1-26.1 million individuals with diabetes annually [3], with the greatest prevalence in patients ages 45 and over. Clinically, it is characterized by skin lesions, gangrene, necrosis, and even after healing there is still a high recurrence rate and amputation [4]. ...
... As one of the most common serious diabetic complications, DFU has been responsible for the majority of leg amputations in diabetic individuals [44]. At present, the common etiopathogenesis of DFU is ascribed to the dysfunctions of the neural systems and the impairment of blood vessels [3,45]. Nowadays, some reports have shown that the failure of wound healing in DFU sufferers is closely associated with abnormal alterations in a variety of biological processes, particularly impaired angiogenesis [46,47]. ...
Background
Diabetic foot ulcers (DFU) are a serious complication of diabetes that lead to significant morbidity and mortality. Recent studies reported that exosomes secreted by human adipose tissue-derived mesenchymal stem cells (ADSCs) might alleviate DFU development. However, the molecular mechanism of ADSCs-derived exosomes in DFU is far from being addressed.
Methods
Human umbilical vein endothelial cells (HUVECs) were induced by high-glucose (HG), which were treated with exosomes derived from nuclear factor I/C (NFIC)-modified ADSCs. MicroRNA-204-3p (miR-204-3p), homeodomain-interacting protein kinase 2 (HIPK2), and NFIC were determined using real-time quantitative polymerase chain reaction. Cell proliferation, apoptosis, migration, and angiogenesis were assessed using cell counting kit-8, 5-ethynyl-2′-deoxyuridine (EdU), flow cytometry, wound healing, and tube formation assays. Binding between miR-204-3p and NFIC or HIPK2 was predicted using bioinformatics tools and validated using a dual-luciferase reporter assay. HIPK2, NFIC, CD81, and CD63 protein levels were measured using western blot. Exosomes were identified by a transmission electron microscope and nanoparticle tracking analysis.
Results
miR-204-3p and NFIC were reduced, and HIPK2 was enhanced in DFU patients and HG-treated HUVECs. miR-204-3p overexpression might abolish HG-mediated HUVEC proliferation, apoptosis, migration, and angiogenesis in vitro. Furthermore, HIPK2 acted as a target of miR-204-3p. Meanwhile, NFIC was an upstream transcription factor that might bind to the miR-204-3p promoter and improve its expression. NFIC-exosome from ADSCs might regulate HG-triggered HUVEC injury through miR-204-3p-dependent inhibition of HIPK2.
Conclusion
Exosomal NFIC silencing-loaded ADSC sheet modulates miR-204-3p/HIPK2 axis to suppress HG-induced HUVEC proliferation, migration, and angiogenesis, providing a stem cell-based treatment strategy for DFU.
... Diabetic foot ulcers (DFUs) are one of the most dangerous complications of diabetes, with a global prevalence of 6.3% among diabetic patients [1]. The 5-year risk of death in patients with DFU is 2.5 times higher than that in patients without DFU, and the 5-year morbidity and mortality rate of patients after amputation exceeds 70% [1,2]. ...
... Diabetic foot ulcers (DFUs) are one of the most dangerous complications of diabetes, with a global prevalence of 6.3% among diabetic patients [1]. The 5-year risk of death in patients with DFU is 2.5 times higher than that in patients without DFU, and the 5-year morbidity and mortality rate of patients after amputation exceeds 70% [1,2]. The pathogenesis of DFU is highly complex and is mostly caused by distal neuropathy and peripheral vascular lesions in the lower extremities. ...
As time goes by, the morbidity of diabetes mellitus continues to rise, and the economic burden of diabetic foot ulcers as a common and serious complication of diabetes is increasing. However, currently there is no unified clinical treatment strategy for this complication, and the therapeutic efficacy is unsatisfactory. Recent studies have revealed that biological effects of exosomes involved in multiple stages of the process of wound closure are similar to source cells. Compared with source cells, exosomes possess lowly immunogenicity, highly stability and easily stored, etc. Accumulating evidence confirmed that exosomes promote diabetic wound healing through various pathways such as promoting angiogenesis, collagen fiber deposition, and inhibiting inflammation. The superior therapeutic efficacy of exosomes in accelerating diabetic cutaneous wound healing has attracted an increasing attention. Notably, the molecular mechanisms of exosomes vary among different sources in the chronic wound closure of diabetes. This review focuses on the specific roles and mechanisms of different cell- or tissue-derived exosomes relevant to wound healing. Additionally, the paper provides an overview of the current pre-clinical and clinical applications of exosomes, illustrates their special advantages in wound repair. Furthermore, we discuss the potential obstacles and various solutions for future research on exosomes in the management of diabetic foot ulcer. The aim is to offer novel insights and approaches for the treatment of diabetic foot ulcer.
... Pengeringan kulit karena neuropati otonom juga merupakan faktor lain yang berkontribusi. Akhirnya, trauma kalus yang sering menyebabkan perdarahan subkutan dan akhirnya terkikis dan menjadi ulserasi (Armstrong et al., 2017). ...
ABSTRAK Neuropati perifer merupakan sebuah penyakit yang mempengaruhi saraf serta menyebabkan gangguan sensasi, gerakan, dan aspek kesehatan lainnya tergantung pada saraf yang terkena. Peripheral Artery Disease (PAD) atau penyakit arteri perifer adalah penyakit pada ekstremitas bawah karena terjadinya penyumbatan arteri yang disebabkan oleh atherosklerosis. Kelainan bentuk kaki disebabkan oleh neuropati diabetes sehingga mengakibatkan peningkatan tekanan kulit saat berjalan. Imunopati terlibat dalam kerentanan yang ada pada pasien diabetes terhadap infeksi serta potensi untuk meningkatkan respons normal inflamasi. Gejala awal neuropati perifer meliputi : rasa nyeri, kesemutan, mati rasa dikaki, tubuh lemah atau hilang keseimbangan dan luka dikaki yang tidak disadari penyebabnya segera lakukan pemeriksaan medis dan menghubungi tenaga medis agar resiko terjadinya komplikasi akibat neuropati perifer dapat dicegah (Indriyani, 2019). Adapun tujuan Penyuluhan Senam Kaki Diabetik Sebagai Pencegahan Luka Kaki Diabetik Pada Tenaga Kesehatan di Karawang Banten adalah agar tenaga kesehatan mengetahui mengenai senam kaki sebagai upaya promosi, dan prevensi di bidang pelayanan Kesehatan. Tenaga Kesehatan mampu memahami senam kaki Mampu meminimalisir kejadian luka kaki. Dalam melakukan senam kaki, sangat penting untuk memahami faktor-faktor yang memperberat resiko terjadinya luka, Perhatikan status kesehatan umum dan adanya penyakit-penyakit tertentu pada pasien yang dapat mempengaruhi resiko terjadinya luka, Dokumentasikan hasil penilaian luka secara sistematis, Manajemen senam kaki sangat penting untuk pencegahan luka. Kata Kunci : Senam kaki Diabetik, Luka Kaki Diabetik ABSTRACT Peripheral neuropathy is a disease that affects the nerves and causes disturbances in sensation, movement, and other aspects of health depending on the nerves affected. Peripheral Artery Disease (PAD) or peripheral arterial disease is a disease of the lower extremities due to blockage of the arteries caused by atherosclerosis. Foot deformities caused by diabetic neuropathy result in increased skin pressure when walking. Immunopathy is implicated in the existing susceptibility of diabetic patients to infection as well as the potential to enhance the normal inflammatory response. Early symptoms of peripheral neuropathy include: pain, tingling, numbness in the legs, weakness or loss of balance and leg injuries that are not recognized as the cause, immediately do a medical examination and contact medical personnel so that the risk of complications due to peripheral neuropathy can be prevented (Indriyani, 2019). The purpose of counseling on diabetic foot exercise as a prevention of diabetic foot injury to health workers in Karawang, Banten is for health workers to know about foot exercise as a means of promotion and prevention in the field of health services. Health workers are able to understand foot exercises Able to minimize the incidence of foot injuries. In doing foot exercises, it is very important to understand the factors that increase the risk of injury, Pay attention to general health status and the presence of certain diseases in patients that can affect the risk of injury, Document the results of systematic wound assessment. Management of foot exercises is very important for wound prevention. Keywords: Diabetic foot exercise, Diabetic Foot Injury
... Pengeringan kulit karena neuropati otonom juga merupakan faktor lain yang berkontribusi. Akhirnya, trauma kalus yang sering menyebabkan perdarahan subkutan dan akhirnya terkikis dan menjadi ulkus (Armstrong et al., 2017). Pasien dengan diabetes mellitus juga mengembangkan aterosklerosis parah pada pembuluh darah kecil di tungkai dan kaki, yang menyebabkan gangguan vaskular, yang merupakan penyebab lain infeksi kaki diabetik. ...
ABSTRAK Luka Kaki diabetik merupakan penyakit vaskular mikroangiopati dan salah satu komplikasi kronik utama diabetes melitusyang terkait 16 makroangiopati, mikroangiopati, neuropat. Organisasi kesehatan dunia (World Health Organization/WHO) jumlah total populasi 9 penderita diabetes tipe 1 dan 2 mencapai 3% dari total jumlah populasi penduduk di seluruh dunia. Prevalensinya sekitar 4-10% di antara populasi penderita diabetes melitus, dengan insiden mengalami luka kaki diabetik selama masa hidup penderitanya mencapai 25%. Luka kaki diabetik dalam jangka waktu yang lama juga memberi dampak negatif pada konsep diri pasien, penghargaan diri sendiri, kualitas hidup, Kesehatan fisik dan emosi, harapan pasien untuk sembuh serta tingkat spiritual pasien. Adapun salah satu dampak dari luka kaki diabetik yaitu amputasi yang dimana itu seharusnya menjadi usaha terakhir yang dilakukan untuk mengatasi persoalan menyelamatkan kaki diabetik. Adapun tujuan Penyuluhan Manajemen Luka Terkini Pada Luka Kaki Diabetik Dalam Situasi Pandemic Covid -19 bagi Para Tenaga Kesehatan di Jakarta selatan dapat mengetahui Manajemen perawatan luka terkini di situasi pandemic covid 19, memberikan edukasi kepada masyarakat tentang upaya promosi, prevensi dan lurasi di bidang Kesehatan kulit di situasi pandemic covid 19, mampu memahami perawatan luka berbasis lembab (Moist), Mampu melaksanakan asuhan keperawatan berupa upaya promotive preventif dan kuratif dan rehabilitative di situasi covid 19. Diperlukan penilaian luka secara menyeluruh meliputi penilaian terhadap faktor predisposisi, faktor prognosis dan penampilan luka. Dokumentasikan hasil penilaian luka secara sistematis. Manajemen luka berbeda untuk tiap jenis luka dan tahapan penyembuhan luka. Lakukan penilaian kembali (re-assessment) secara periodik untuk menyesuaikan penatalaksanaan yang akan diberikan. Kata Kunci: Perawatan Luka Terkini, Luka Kaki Diabetik ABSTRACT Diabetic foot ulcers are a microangiopathic vascular disease and one of the main chronic complications of diabetes mellitus associated with macroangiopathy, microangiopathy, and neuropathies. The World Health Organization (WHO) estimates that the total population of 9 people with type 1 and 2 diabetes reaches 3% of the total population worldwide. Its prevalence is around 4-10% among the population with diabetes mellitus, with the incidence of experiencing diabetic foot sores during the sufferer's lifetime reaching 25%. Diabetic foot wounds in the long term also have a negative impact on the patient's self-concept, self-esteem, quality of life, physical and emotional health, the patient's hope for recovery and the patient's spiritual level. As for one of the effects of diabetic foot wounds, namely amputation which should be the last resort made to overcome the problem of saving diabetic feet. The aim of Counseling on the Latest Wound Management on Diabetic Foot Wounds in a Pandemic Covid -19 Situation for Health Workers in South Jakarta can find out the latest Wound care Management in a situation of the Covid 19 pandemic, provide education to the public about promotion of efforts, prevention and resolution in the field of Skin health in the covid 19 pandemic situation, able to understand moisture-based wound care (Moist), able to carry out pain relief in the form of preventive and curative and rehabilitative promotive efforts in the covid 19 situation. A thorough wound assessment is required including an assessment of predisposing factors, prognostic factors and wound appearance. Document the results of wound judgment in a systematic manner. Wound management is different for each type of wound and the stages of wound healing. Carry out periodic re-assessments to adjust the management that will given. Keywords: Latest Wound Care, Diabetic Foot Wound
... However, the 128-Hz tuning fork does not provide quantitative information about the degree of loss of vibration sensation. Quantitative testing of vibration sensation is important as impaired vibration perception can also be predictive of the risk of foot ulceration [7][8][9]. The Rydel-Seiffer graduated tuning fork can evaluate vibration perception threshold (VPT) on a scale of 0-8 and has been standardized for quantitative sensory testing (QST) [10]. ...
Aims
Peripheral neuropathy is a common microvascular complication in diabetes and a risk factor for the development of diabetic foot ulcers and amputations. Vibrasense (Ayati Devices) is a handheld, battery-operated, rapid screening device for diabetic peripheral neuropathy (DPN) that works by quantifying vibration perception threshold (VPT). In this study, we compared Vibrasense against a biothesiometer and nerve conduction study for screening DPN.
Methods
A total of 562 subjects with type 2 diabetes mellitus underwent neuropathy assessments including clinical examination, 10-g monofilament test, VPT evaluation with Vibrasense and a standard biothesiometer. Those with an average VPT ≥ 15 V with Vibrasense were noted to have DPN. A subset of these patients ( N = 61) underwent nerve conduction study (NCS). Diagnostic accuracy of Vibrasense was compared against a standard biothesiometer and abnormal NCS.
Results
Average VPTs measured with Vibrasense had a strong positive correlation with standard biothesiometer values (Spearman’s correlation 0.891, P < 0.001). Vibrasense showed sensitivity and specificity of 87.89% and 86.81% compared to biothesiometer, and 82.14% and 78.79% compared to NCS, respectively.
Conclusions
Vibrasense demonstrated good diagnostic accuracy for detecting peripheral neuropathy in type 2 diabetes and can be an effective screening device in routine clinical settings.
Trial registration
Clinical trials registry of India (CTRI/2022/11/047002). Registered 3 November 2022. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=76167 .
... . One in three diabetic patients experiences diabetic foot ulcers (DFU), which are 34% more likely to occur in people with diabetes over their lifetime [2]. The massive increase in DFU prevalence over the past few decades has posed a critical challenge to global healthcare systems. ...
Diabetes related complications such as Diabetic Foot Ulcers (DFU) may necessitate recurrent hospitalisations and expensive treatments. Uncontrolled diabetes can result in severe DFUs, resulting in amputation of lower limbs or feet, prolonged debilitation and diminished quality of life. Early diagnosis and proactive management are reported to significantly enhance the prognosis and reduce the onset of further complications. In this study, research works on developing clinical decision support systems (CDSS) for the identification and segmentation of DFU are systematically reviewed. The techniques employed range from traditional image processing techniques to approaches based on deep learning (DL). A taxonomy of DFU CDSSs is presented, categorised into two groups: RGB-based techniques and thermal imaging-based approaches. To the best of our knowledge, this is the first attempt at a comprehensive study of CDSSs for DFU related investigative tasks, based on different imaging modalities. We also delve into the difficulties experienced in the process of creating efficient, reliable, and accurate models for the early detection of DFU, and highlight the vast potential for further research in this emerging domain.
... Foot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity [2][3][4][5][6][7]. Nearly 34% of people with diabetes will develop a foot ulcer in their lifetime [8]. This can lead to infection and amputation; diabetes is the main reason for nontraumatic amputation [9,10]. ...
... The development of chronic diabetic wounds is mostly caused by diminished GF production, cellular migration, proliferation, angiogenic response, and collagen accumulation, and the unbalanced accumulation of extracellular matrix (ECM) components and matrix metalloproteinases (MMPs) [31,32]. In addition, there are suggestions that the reduced activity of various signalling pathways including insulin, AMP-activated protein kinase (AMPK), and ligand-activated transcription factor pathways such as peroxisome proliferator-activated receptors (PPARs), may play a critical role in the development of chronic diabetic wounds [33,34]. ...
The induction of a cells destiny is a tightly controlled process that is regulated through communication between the matrix and cell signalling proteins. Cell signalling activates distinctive subsections of target genes, and different signalling pathways may be used repeatedly in different settings. A range of different signalling pathways are activated during the wound healing process, and dysregulated cellular signalling may lead to reduced cell function and the development of chronic wounds. Diabetic wounds are chronic and are characterised by the inability of skin cells to act in response to reparative inducements. Serine/threonine kinase, protein kinase B or AKT (PKB/AKT), is a central connection in cell signalling induced by growth factors, cytokines and other cellular inducements, and is one of the critical pathways that regulate cellular proliferation, survival, and quiescence. AKT interacts with a variety of other pathway proteins including glycogen synthase kinase 3 beta (GSK3β) and β-catenin. Novel methodologies based on comprehensive knowledge of activated signalling pathways and their interaction during normal or chronic wound healing can facilitate quicker and efficient diabetic wound healing. In this review, we focus on interaction of the AKT and β-catenin signalling pathways and the influence of photobiomodulation on cellular signalling proteins in diabetic wound healing.
... Diabetic foot ulcer (DFU) is a prevalent complication of diabetes, which is an important factor leading to disability and death of diabetes patients. It is reported that 19-34% of diabetes may be affected by DFU in their lifetime [1]. Patients with DFUs have a lower quality of life and poorer psychological adjustment, which imposes a huge economic burden on families and society [2]. ...
Objective
Diabetes foot ulcer (DFU) is a serious complication of diabetes, which can lead to significant mortality and amputation rate. Our previous study found circ_072697 was highly expressed in DFU tissues, but the regulatory mechanism of circ_072697 in DFU remains unclear.
Methods
The relative expressions of circ_072697, miR-3150a-3p, and KDM2A in DFU patients or advanced glycation end products (AGEs)-treated HaCaT cells (used as DFU cell model) were determined by using qRT-PCR. Cell proliferation and migration abilities were determined by using CCK-8 and Transwell assays. The interaction between miR-3150a-3p with circ_072697 or KDM2A were verified by RNA immunoprecipitation (RIP) and dual-luciferase reporter assays. Furthermore, the protein expression of genes involved in MAPK signaling pathway was detected by western blot.
Results
The expression of circ_072697 was significantly upregulated in DFU tissues, while the expression of miR-3150a-3p was downregulated. Circ_072697 knockdown promoted the proliferation and migration of AGEs-treated HaCaT cells. miR-3150a-3p was confirmed as a target of circ_072697 and its inhibitor reversed the promotion effects of circ_072697 knockdown on biological behavior of cells. In addition, KDM2A was considered as a target of miR-3150a-3p and it was highly expressed in DFU samples. Importantly, circ_072697 could regulate KDM2A expression through sponging miR-3150a-3p, and this axis had effect on the MAPK signaling pathway.
Conclusions
Overall, circ_072697 regulated the biological behaviors of keratinocytes in DFU via miR-3150a-3p/KDM2A axis and MAPK signaling pathway, revealing a new insight into the pathogenesis and potential therapeutic targets of DFU.
... Foot infections are frequent complications of diabetes mellitus that are associated with high morbidity, occasional mortality, and heavy resource utilisation, including antibiotic therapy and surgical procedures. [1][2][3] The yearly incidence of diabetic foot ulcers (DFUs) is about 2% with a lifetime incidence between 19% and 34%, 4 and about half of these ulcers become infected. Approximately 20% of moderate and severe diabetic foot infections (DFIs) result in amputation, 3 In 2019, we performed a systematic review of these topics, which was published in this journal in 2020. ...
Background
Securing an early accurate diagnosis of diabetic foot infections and assessment of their severity are of paramount importance since these infections can cause great morbidity and potential mortality and present formidable challenges in surgical and antimicrobial treatment.
Methods
In June 2022, we searched the literature using PubMed and EMBASE for published studies on the diagnosis of diabetic foot infection (DFI). On the basis of pre‐determined criteria, we reviewed prospective controlled, as well as non‐controlled, studies in English. We then developed evidence statements based on the included papers.
Results
We selected a total of 64 papers that met our inclusion criteria. The certainty of the majority of the evidence statements was low because of the weak methodology of nearly all of the studies. The available data suggest that diagnosing diabetic foot infections on the basis of clinical signs and symptoms and classified according to the International Working Group of the Diabetic Foot/Infectious Diseases Society of America scheme correlates with the patient's likelihood of the need for hospitalisation, lower extremity amputation, and risk of death. Elevated levels of selected serum inflammatory markers such as erythrocyte sedimentation rate (ESR), C‐reactive protein and procalcitonin are supportive, but not diagnostic, of soft tissue infection. Culturing tissue samples of soft tissues or bone, when care is taken to avoid contamination, provides more accurate microbiological information than culturing superficial (swab) samples. Although non‐culture techniques, especially next‐generation sequencing, are likely to identify more bacteria from tissue samples including bone than standard cultures, no studies have established a significant impact on the management of patients with DFIs. In patients with suspected diabetic foot osteomyelitis, the combination of a positive probe‐to‐bone test and elevated ESR supports this diagnosis. Plain X‐ray remains the first‐line imaging examination when there is suspicion of diabetic foot osteomyelitis (DFO), but advanced imaging methods including magnetic resonance imaging (MRI) and nuclear imaging when MRI is not feasible help in cases when either the diagnosis or the localisation of infection is uncertain. Intra‐operative or non‐per‐wound percutaneous biopsy is the best method to accurately identify bone pathogens in case of a suspicion of a DFO. Bedside percutaneous biopsies are effective and safe and are an option to obtain bone culture data when conventional (i.e. surgical or radiological) procedures are not feasible.
Conclusions
The results of this systematic review of the diagnosis of diabetic foot infections provide some guidance for clinicians, but there is still a need for more prospective controlled studies of high quality.
... Patients with diabetes are at risk of developing diabetic foot ulcers in approximately 19 to 34% of cases during their lifetime, and approximately 50% of these cases become infected [66,67]. Several studies have identified risk factors for the development of DFIs, including a mean duration of diabetic foot ulcers >30 days, trauma as the cause, wound extension to the bone, recurrent wounds, previous amputation surgery, peripheral arterial disease, loss of protective sensation, and renal failure [68][69][70][71]. ...
This case report describes a 47-year-old man with type 2 diabetes and its associated complications. The patient developed co-infection with methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant (MDR) extended-spectrum ß-lactamase (ESBL)-producing Escherichia coli following surgical amputation for osteomyelitis caused by diabetic foot infection (DFI). The patient had a history of recurrent hospitalization due to DFI and had received multiple antimicrobials. Intraoperative wound cultures identified MRSA and MDR ESBL-producing E. coli as the causative agents of the co-infection. Intravenous vancomycin and meropenem were administered. After surgery, daily debridement and hyperbaric oxygen therapy were performed. The patient underwent surgical wound closure and was discharged on day 86. Polymicrobial infections in DFIs worsen antimicrobial resistance, impede wound healing, and increase the risk of osteomyelitis and amputation. Furthermore, infections caused by MDR bacteria exacerbate challenges in infection control, clinical treatment, and patient outcomes. In DFI cases caused by co-infection with MDR bacteria, prompt and appropriate antimicrobial therapy, debridement, and regular wound care while considering transmission are essential.
... Diabetes mellitus (DM) has become one of the leading causes of disability, affecting up to 537 million patients worldwide in 2021 [1]. Among the DM-related morbidities, chronic ulcer is one of the most common and costly complications, likely impacting 19-34% of diabetic patients [2]. Diabetic wounds are multifactorial, involving impaired wound epithelialization, angiogenesis and collagen matrix formation [3,4]. ...
Background
Application of autologous adipose-derived stem cells (ASC) for diabetic chronic wounds has become an emerging treatment option. However, ASCs from diabetic individuals showed impaired cell function and suboptimal wound healing effects. We proposed that adopting a low-glucose level in the culture medium for diabetic ASCs may restore their pro-healing capabilities.
Methods
ASCs from diabetic humans and mice were retrieved and cultured in high-glucose (HG, 4.5 g/L) or low-glucose (LG, 1.0 g/L) conditions. Cell characteristics and functions were investigated in vitro. Moreover, we applied diabetic murine ASCs cultured in HG or LG condition to a wound healing model in diabetic mice to compare their healing capabilities in vivo.
Results
Human ASCs exhibited decreased cell proliferation and migration with enhanced senescence when cultured in HG condition in vitro. Similar findings were noted in ASCs derived from diabetic mice. The inferior cellular functions could be partially recovered when they were cultured in LG condition. In the animal study, wounds healed faster when treated with HG- or LG-cultured diabetic ASCs relative to the control group. Moreover, higher collagen density, more angiogenesis and cellular retention of applied ASCs were found in wound tissues treated with diabetic ASCs cultured in LG condition.
Conclusions
In line with the literature, our study showed that a diabetic milieu exerts an adverse effect on ASCs. Adopting LG culture condition is a simple and effective approach to enhance the wound healing capabilities of diabetic ASCs, which is valuable for the clinical application of autologous ASCs from diabetic patients.
... With this comes a rise in the associated development of diabetic foot disease. From this population it is expected up to 25% will develop diabetic foot ulceration (DFU) within their lifetime (Armstrong et al., 2017). The associated healing times and treatment pathway requirements for DFU lead to a labour and cost intensive process with over £900 million spent annually in the UK market alone (Kerr et al., 2019), which is neither beneficial to the patient or healthcare provider. ...
Introduction: Under plantar loading regimes, it is accepted that both pressure and shear strain biomechanically contribute to formation and deterioration of diabetic foot ulceration (DFU). Plantar foot strain characteristics in the at-risk diabetic foot are little researched due to lack of measurement devices. Plantar pressure comparatively, is widely quantified and used in the characterisation of diabetic foot ulceration risk, with a range of clinically implemented pressure measurement devices on the market. With the development of novel strain quantification methods in its infancy, feasibility testing and validation of these measurement devices for use is required. Initial studies centre on normal walking speed, reflecting common activities of daily living, but evaluating response to differing gait loading regimes is needed to support the use of such technologies for potential clinical translation. This study evaluates the effects of speed and inclination on stance time, strain location and strain response using a low-cost novel strain measurement insole.
Methods: The STrain Analysis and Mapping of the Plantar Aspect (STAMPS) insole has been developed, and feasibility tested under self-selected normal walking speeds to characterise plantar foot strain, with testing beyond this limited regime required. A treadmill was implemented to standardise speed and inclination for a range of daily plantar loading conditions. A small cohort, comprising of five non-diabetic participants, were examined at slow (0.75 m/s), normal (1.25 m/s) and brisk (2 m/s) walking speeds and normal speed at inclination (10% gradient).
Results: Plantar strain active regions were seen to increase with increasing speed across all participants. With inclination, it was seen that strain active regions reduce in the hindfoot and show a tendency to forefoot with discretionary changes to strain seen. Stance time decreases with increasing speed, as expected, with reduced stance time with inclination.
Discussion: Comparison of the strain response and stance time should be considered when evaluating foot biomechanics in diabetic populations to assess strain time interval effects. This study supports the evaluation of the STAMPS insole to successfully track strain changes under differing plantar loading conditions and warrants further investigation of healthy and diabetic cohorts to assess the implications for use as a risk assessment tool for DFU.
Chronic wounds like diabetic foot ulcers (DFU) can result in significant medical issues like limb amputation, infection, sepsis, and even death. In those with DFU, 65% recur within 5 years after wound closure. Infection is a common complication of DFU. Biofilm infection of wound may result in a state where the wound appears closed (visually, standard of care as per US FDA) but is actually not because barrier function has been compromised. Such barrier function-deficient skin exhibits compromised biomechanical properties of closed wounds and favors wound recurrence. Hence, continuous care is warranted until functional wound closure is achieved to minimize recurrence and amputation. Here we enlist different structural, molecular, and metabolic variables that should be investigated to determine if a wound has functionally closed. Additionally, this chapter explains why measurement of skin barrier function (as expressed by transepidermal water loss or TEWL) is being investigated by NIH Diabetic Foot Consortium (DFC) as the new biomarker that may predict DFU wound recurrence.
Diabetic foot wounds are one of the most common long-term complications of chronic hyperglycemia and a major source of morbidity and mortality for patients. Even with appropriate treatment, many patients may eventually require a major amputation or a limb salvage operation. This chapter provides an overview of the epidemiology of diabetic foot ulcers and special considerations for limb salvage versus amputation.
The growing prevalence of diabetes and the subsequent increase in diabetic complications such as diabetic foot ulcers (DFUs) are a major concern. The lack of universal guidelines to manage DFU presents a constellation of challenges in wound management. Over the past decade, there has been growing evidence suggesting that a multidisciplinary team is the ideal approach to manage these wounds. In this chapter a framework for building a multidisciplinary disciplinary team targeted toward functional limb salvage in the diabetic will be discussed.
Diabetes affects more than 13% of people in the USA and poses a major risk of comorbid complications such as neuropathy, ocular disease, and diabetic foot ulcers. It also places a significant financial burden on both patients and healthcare systems. Thirty-four percent of diabetic patients go on to develop foot ulcers, and despite optimized standard wound care in these patients, many of these wounds persist and put patients at risk for infection, hospitalization, and amputation. Therefore, adjuvant therapies, including negative pressure therapy, hyperbaric oxygen therapy, and tissue products, are particularly important in these patients with wounds recalcitrant to the standard of care (SOC). Tissue products are any biologic skin substitutes that aid in wound healing and can be divided into 4 broad categories: allografts/xenografts, dermal substitutes, biosynthetic dressing, and cultured skin grafts. Collectively, tissue products have shown modest decreases in healing time over SOC alone, and there is some evidence of slightly fewer amputations in patients treated with these skin substitutes. However, the effect on limb salvage is not significant enough to draw any definitive conclusions. Among the tissue products, dermal substitutes demonstrate the most significant effects over SOC. Tissue products show decreased cost-effectiveness when compared to SOC, but the additional cost is offset by their long-term impact on amputation rates, ulcer-free weeks, emergency department visits, and hospital readmissions. As new tissue products continue to come on the market, it is important that we critically evaluate not only their ability to decrease wound healing time but also their cost to patients and healthcare systems.
The evolution is continuing in the field for diabetic foot reconstruction.
The advent of supermicrosurgery and the other advanced techniques described in this chapter have expanded the possibilities for reconstruction and decreased the morbidity associated with traditional flap surgery. This chapter describes the use of these tools that has allowed us to shift our goals from “obtaining coverage” to creating individualized and elegant reconstructions that seek to provide the best functional outcomes for the patient. Key elements for success in reconstruction are obtaining considerable knowledge of underlying pathophysiology, disease progression, and functional consequences of salvage versus amputation. Successful outcomes can only be obtained in a multidisciplinary setting and by careful planning in concert with flawless technical execution.
Peripheral arterial disease (PAD) is considered a marker disease of multi-locular atherosclerosis and is associated with a high risk of cardiovascular events. PAD is both underdiagnosed and undertreated in everyday clinical practice. The disease is often asymptomatic and is often only diagnosed at an advanced stage, especially in diabetics. Therefore, the early diagnosis of PAD is of central importance to provide patients with stage-appropriate therapy at an early stage.
Lattice structures are a unique class of architected materials characterized by their array of spatial periodic unit cells. These structures can be designed and engineered to provide a range of desired mechanical properties. Their excellent energy absorption properties make lattice structures well-suited for the design of shoe soles. Leveraging the geometric complexity of additively manufactured parts, the mechanical properties of architected materials, and accurate non-intrusive medical data, this research proposes an algorithmic modeling approach for designing customized lattice shoe soles. By integrating conformal and functionally graded lattices with various unit cell types placed throughout the structure based on plantar pressure data, the flexibility of the sole can be controlled locally in areas with high plantar pressure. This can help reduce ground reaction forces during walking and standing, minimizing negative effects on foot health and increasing comfort for the wearer. We leveraged volumetric modeling techniques for error-free Boolean operations and reliable geometry smoothing. In this manner, our algorithm generates an STL file that contains a watertight mesh, ready to be imported into the slicing software.
Fibroblast activation disorder is one of the main pathogenic characteristics of diabetic wounds. Orchestrated fibroblast functions and myofibroblast differentiation are crucial for wound contracture and extracellular matrix (ECM) formation. Pyruvate dehydrogenase kinase 4 (PDK4), a key enzyme regulating energy metabolism, has been implicated in modulating fibroblast function, but its specific role in diabetic wounds remains poorly understood. In this study, we investigated the impact of PDK4 on diabetic wounds and its underlying mechanisms. To assess the effect of PDK4 on human dermal fibroblasts (HDFs), we conducted CCK‐8, EdU proliferation assay, wound healing assay, transwell assay, flow cytometry, and western blot analyses. Metabolic shifts were analyzed using the Seahorse XF analyzer, while changes in metabolite expression were measured through LC–MS. Local recombinant PDK4 administration was implemented to evaluate its influence on wound healing in diabetic mice. Finally, we found that sufficient PDK4 expression is essential for a normal wound‐healing process, while PDK4 is low expressed in diabetic wound tissues and fibroblasts. PDK4 promotes proliferation, migration, and myofibroblast differentiation of HDFs and accelerates wound healing in diabetic mice. Mechanistically, PDK4‐induced metabolic reprogramming increases the level of succinate that inhibits PHD2 enzyme activity, thus leading to the stability of the HIF‐1α protein, during which process the elevated HIF‐1α mRNA by PDK4 is also indispensable. In conclusion, PDK4 promotes fibroblast functions through regulation of HIF‐1α protein stability and gene expression. Local recombinant PDK4 administration accelerates wound healing in diabetic mice.
Diabetic foot ulcer, is a chronic complication afflicting individuals with diabetes, continue to increase worldwide, immensely burdening society. Programmed cell death, which includes apoptosis, autophagy, ferroptosis, necroptosis and pyroptosis, has been increasingly implicated in the pathogenesis of diabetic foot ulcer. This review is based on an exhaustive examination of the literature on ‘programmed cell death’ and ‘diabetic foot ulcers’ via PubMed. The findings revealed that natural bioactive compounds, noncoding RNAs and certain proteins play crucial roles in the healing of diabetic foot ulcers through various forms of programmed cell death, including apoptosis, autophagy, ferroptosis and pyroptosis.
Purpose of Review
Diabetes mellitus is a chronic medical condition affecting many individuals worldwide and leads to billions of dollars spent within the healthcare system for its treatment and complications. Complications from diabetes include diabetic foot conditions that can have a devasting impact on quality of life. Diabetic foot ulcers and amputations occur in minority individuals at an increased rate compared to Caucasian individuals. This review provides an update examining the racial and ethnic disparities in the management of diabetic foot conditions and the differences in rates of amputation.
Recent Findings
Current research continues to show a disparity as it relates to diabetic foot management. There are novel treatment options for diabetic foot ulcers that are currently being explored. However, there continues to be a lack in racial diversity in new treatment studies conducted in the USA.
Summary
Individuals from racial and ethnic minority groups have diabetes at higher rates compared to Caucasian individuals, and are also more likely to develop diabetic foot ulcers and receive amputations. Over the last few years, more efforts have been made to improve health disparities. However, there needs to be an improvement in increasing racial diversity when investigating new therapies for diabetic foot ulcers.
Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post‐surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
Aim
To quantify the impact of foot complications on mortality outcomes in people with type 2 diabetes (T2D), and how routinely measured factors might modulate that risk.
Materials and Methods
Data for individuals with T2D for 2010‐2020, from the Salford Integrated Care Record (Salford, UK), were extracted for laboratory and clinical data, and deaths. Annual expected deaths were taken from Office of National Statistics mortality data. An index of multiple deprivation (IMD) adjusted the standardized mortality ratio (SMR_IMD). Life years lost per death (LYLD) was estimated from the difference between expected and actual deaths.
Results
A total of 11 806 T2D patients were included, with 5583 new diagnoses and 3921 deaths during 2010‐2020. The number of expected deaths was 2135; after IMD adjustment, there were 2595 expected deaths. Therefore, excess deaths numbered 1326 (SMR_IMD 1.51). No foot complications were evident in n = 9857. This group had an SMR_IMD of 1.13 and 2.74 LYLD. In total, 2979 patients had any foot complication recorded. In this group, the SMD_IMR was 2.29; of these, 2555 (75%) had only one foot complication. Patients with a foot complication showed little difference in percentage HbA1c more than 58 mmol/mol. In multivariate analysis, for those with a foot complication and an albumin‐to‐creatinine ratio of more than 3 mg/mmol, the odds ratio (OR) for death was 1.93, and for an estimated glomerular filtration rate of less than 60 mL/min/1.73m ² , the OR for death was 1.92.
Conclusions
Patients with T2D but without a foot complication have an SMR_IMD that is only slightly higher than that of the general population. Those diagnosed with a foot complication have a mortality risk that is double that of those without T2D.
Bacterial cellulose (BC) and photothermal hydrogels are widely used currently in wound repair. However, modified and functionalized BC maybe damage the advantages of natural BC that limits its application as a wound dressing, and photothermal hydrogels have problem of secondary damage about overheating during photothermal therapy process. Therefore, we develop a Tai-Chi hydrogel inspired by the Chinese philosophy of “Tai Chi”, which is consist of BC, namely Yin, and polyvinyl alchol/polydopamine (PVA/PDA), namely Yang. Two hydrogels of Tai-Chi hydrogel have opposite properties to selectively cover on healthy skin and the wound, to adjust/balance the wound temperature under NIR irradiation. In vitro experiments demonstrate that mild warm caused by Yang hydrogel under NIR irradiation promote polarization of RAW 264.7 macrophages to M2 phenotype. Tai-Chi hydrogel itself has a significant therapeutic effect on diabetic wound by regulating inflammatory microenvironment. In addition, Tai-Chi hydrogel in combination with NIR irradiation exhibited remarkably therapeutic effect by promoting re-epithelialization and angiogenesis, accelerating collagen deposition and macrophages polarization to M2 phenotype. This work firstly presents the novel strategy in designing functional materials with opposite properties inspired by the philosophy of "Yin-Yang" in “Tai Chi” as diabetic wound dressing.
Background
The current treatments for diabetic foot ulcers have disadvantages of slow action and numerous complications. Tibial cortex transverse transport (TTT) surgery is an extension of the Ilizarov technique used to treat diabetic foot ulcers, and can shorten the repair time of diabetic foot ulcers. This study assessed the TTT technique for its effectiveness in healing diabetic foot ulcer skin lesions and its related molecular mechanisms.
Methods
Diabetic rat models were established by injecting healthy Sprague-Dawley rats with streptozotocin (STZ). The effects of TTT surgery on the model rats were assessed by recording changes in body weight, analyzing skin wound pictures, and performing H&E staining to assess the recovery of wounded skin. The numbers of endothelial progenitor cells (EPCs) in peripheral blood were analyzed by flow cytometry, and levels of CXCR4 and SDF-1 expression were qualitatively analyzed by immunofluorescence, immunohistochemistry, qRT-PCR, and western blotting.
Results
Both the histological results and foot wound pictures indicated that TTT promoted diabetic wound healing. Flow cytometry results showed that TTT increased the numbers of EPCs in peripheral blood as determined by CD34 and CD133 expression. In addition, activation of the SDF-1/CXCR4 signaling pathway and an accumulation of EPCs were observed in skin ulcers sites after TTT surgery. Finally, the levels of SDF-1 and CXCR4 mRNA and protein expression in the TTT group were higher than those in a blank or fixator group.
Conclusion
TTT promoted skin wound healing in diabetic foot ulcers possibly by activating the SDF-1/CXCR4 signaling pathway.
PURPOSE
The purpose of this quality improvement initiative was to determine the impact of a nurse-administered foot care intervention bundle (NA-FCIB) upon self-management knowledge, skills, and outcomes in patients with diabetic foot ulcerations.
PARTICIPANTS AND SETTING
The sample comprised 39 patients being treated for diabetic foot ulceration at a wound care clinic in a tertiary care hospital in Arlington, Virginia. The project was conducted from August 2017 to February 2018.
APPROACH
This quality improvement project used the Johns Hopkins Plan-Do-Study-Act Method supplemented by self-regulation theory for diabetic patient education and evidence in clinical literature. The 12-week-long intervention included one-on-one teaching in the prevention of ulcerations and optimal care of the diabetic foot, blood glucose level tracking logs, patient “teach-back” and skills demonstration, and free foot care tools.
OUTCOMES
From baseline to post-NA-FCIB, the number of participants knowing the reasons for temperature foot protection increased by 92%, those knowing major factors leading to diabetic foot ulceration by 85%, those knowing what to look for in the foot self-exam by 85%, and those able to demonstrate correct foot self-exam by 84%. The number of participants understanding proper footwear increased by 74%, and those identifying ways to avoid/decrease the likelihood of diabetic foot ulcers by 72%. Mean serum hemoglobin A 1c (HgbA 1c ) levels decreased from baseline to postintervention (8.27%; SD 2.05% vs 7.46%; SD 1.58%; P = .002).
IMPLICATIONS FOR PRACTICE
The NA-FCIB intervention was successfully incorporated into routine clinic care as the standard of care. Our experience suggests that the NA-FCIB may be feasible and effective for use at comparable wound care clinics and may have secondary benefits for HgbA 1c regulation.
Lower extremity wound management in patients with peripheral vascular disease can be daunting. The initial assessment consists of a physical exam of the wound, vascular status stratification, and risk factor modification (i.e., diabetes, nutrition, and infection). Based on this, the wound can be classified and then managed. Management is an important skill to have in limb preservation, consisting of both wound care techniques and treatment of the underlying causes. There is a wide array of wound care techniques from basic dressings to advanced surgical options. Advancements in surgical options have allowed for improved function, meaningful recovery, and limb preservation in these patients. Many factors related to health status, vascular integrity, and wound characteristics are evaluated to determine the appropriate technique for manage`ment.
Changes in the feet occur with age which can cause pain and other foot pathologies that can lead to falls, foot ulcers and amputation. Some older adults may have difficulty doing foot hygiene due to physical or mental decline such as body habitus, poor vision, arthritic problems to mention a few.1 The presence of PAD creates an increased risk of foot ulcers, leg/foot infection and lower extremity amputation, especially in diabetic patients. PAD is often asymptomatic;2 however PAD prevalence increases with age, the majority of which occurs over age 65.3 African-American and Native Americans have approximately twice the prevalence of PAD than that of non-Hispanic Whites.4 There is a 40% rate of death at 5 years following the development of a foot ulcer in PAD patients.5 Foot ulcers require increased medical office visits, increased resource utilization, increased patient anxiety/depression and reduced quality of life (QOL).6 However, routine foot examinations and educating patients and their families in proper footcare can detect common foot problems, uncover functional decline and PAD, and prevent falls. In patients at-risk for foot ulcers, a yearly comprehensive foot evaluation can prevent foot ulcers, foot pain, and lower extremity amputation. Evaluation and early recognition of PAD can reduce morbidity and mortality.6,8,13.
Diabetic foot ulcers (DFUs) are a severe complication among diabetic patients and often result in amputation and even mortality. Early recognition of infection and ischemia is crucial for improved healing, but current methods are invasive, time-consuming, and expensive. To address this need, we have developed DFUCare, a platform that uses computer vision and deep learning (DL) algorithms to non-invasively localize, classify, and analyze DFUs. The platform uses a combination of CIELAB and YCbCr color space segmentation with a pre-trained YOLOv5s algorithm for wound localization achieving an F1-score of 0.80 and an mAP of 0.861. Using DL algorithms to identify infection and ischemia, we achieved a binary accuracy of 79.76% for infection classification and 94.81% for ischemic classification on a validation set. DFUCare also measures wound size and performs tissue color and textural analysis to allow comparative analysis of macroscopic features of the wound. We tested DFUCare performance in a clinical setting to analyze the DFUs collected using a cell phone camera. DFUCare successfully segmented the skin from the background, localized the wound with less than 10% error, and predicted infection and ischemia with less than 10% error. This innovative approach has the potential to deliver a paradigm shift in diabetic foot care by providing a cost-effective, remote, and convenient healthcare solution.
PurposeThis study aimed to investigate the effects of photobiomodulation (PBM) and conditioned medium (CM) derived from human adipose-derived stem cells (h-ASCs), both individually and in combination, on the maturation stage of an ischemic infected delayed healing wound model (IIDHWM) in type I diabetic (TIDM) rats.Methods
The study involved the extraction of h-ASCs from donated fat, assessment of their immunophenotypic markers, cell culture, and extraction and concentration of CM from cultured 1 × 10^6 h-ASCs. TIDM was induced in 24 male adult rats, divided into four groups: control, CM group, PBM group (80 Hz, 0.2 J/cm2, 890 nm), and rats receiving both CM and PBM. Clinical and laboratory evaluations were conducted on days 4, 8, and 16, and euthanasia was performed using CO2 on day 16. Tensiometrical and stereological examinations were carried out using two wound samples from each rat.ResultsAcross all evaluated factors, including wound closure ratio, microbiological, tensiometrical, and stereological parameters, similar patterns were observed. The outcomes of CM + PBM, PBM, and CM treatments were significantly superior in all evaluated parameters compared to the control group (p = 0.000 for all). Both PBM and CM + PBM treatments showed better tensiometrical and stereological results than CM alone (almost all, p = 0.000), and CM + PBM outperformed PBM alone in almost all aspects (p = 0.000). Microbiologically, both CM + PBM and PBM exhibited fewer colony-forming units (CFU) than CM alone (both, p = 0.000).ConclusionPBM, CM, and CM + PBM interventions substantially enhanced the maturation stage of the wound healing process in IIDHWM of TIDM rats by mitigating the inflammatory response and reducing CFU count. Moreover, these treatments promoted new tissue formation in the wound bed and improved wound strength. Notably, the combined effects of CM + PBM surpassed the individual effects of CM and PBM.
The number of diabetic foot ulcer patients is substantially increasing, with the rapidly rising burden of diabetic mellitus in sub-Saharan Africa. The data on the regional prevalence of diabetic foot ulcer infecting bacteria and their antimicrobial resistance patterns is crucial for its proper management. This systematic review and meta-analysis determined the pooled prevalence of bacterial profiles and antimicrobial resistance patterns of infected diabetic foot ulcers in sub-Saharan Africa. A comprehensive search of the literature was performed on CINAHL, EMBASE, Google Scholar, PubMed, Scopus, and Web of Science databases. Critical appraisal was done using the Joanna Briggs Institute’s tool for prevalence studies. A pooled statistical meta-analysis was conducted using STATA Version 17.0. The I² statistics and Egger’s test were used to assess the heterogeneity and publication bias. The pooled prevalence and the corresponding 95% confidence interval of bacterial profiles and their antimicrobial resistance patterns were estimated using a random effect model. Eleven studies with a total of 1174 study participants and 1701 bacteria isolates were included. The pooled prevalence of the most common bacterial isolates obtained from DFU were S. aureus (34.34%), E. coli (21.16%), and P. aeruginosa (20.98%). The highest pooled resistance pattern of S. aureus was towards Gentamicin (57.96%) and Ciprofloxacin (52.45%). E.coli and K. Pneumoniae showed more than a 50% resistance rate for the most common antibiotics tested. Both gram-positive and gram-negative bacteria were associated with diabetic foot ulcers in sub-Saharan Africa. Our findings are important for planning treatment with the appropriate antibiotics in the region. The high antimicrobial resistance prevalence rate indicates the need for context-specific effective strategies aimed at infection prevention and evidence-based alternative therapies.
Due to the complex microenvironment and healing process of diabetic wounds, developing wound dressing with good biocompatibility, mechanical stability, breathability, exudate management, antibacterial ability, and immunomodulatory property is highly desired but remains a huge challenge. Herein, a multifunctional cryogel is designed and prepared with bio‐friendly bacterial cellulose, gelatin, and dopamine under the condition of sodium periodate oxidation. Bacterial cellulose can enhance the mechanical stability of the cryogel by improving the skeleton supporting effect and crosslinking degree. The cryogel shows outstanding breathability and exudate management capability thanks to the interpenetrated porous structures. I2 and sodium iodides produced in situ by reduction of sodium periodate provide efficient antibacterial properties for the cryogel. The cryogel facilitates macrophage polarization from M1 to M2, thus regulating the immune microenvironment of infected diabetic wounds. With these advantages, the multifunctional cryogel effectively promotes collagen deposition and neovascularization, thus accelerating the healing of infected diabetic wounds.
Objective:
To evaluate ambulatory clinical cases of diabetic foot ulcers (DFUs) and diabetic foot infections (DFIs) in the U.S. from 2007 to 2013 and to assess outcomes of emergency department or inpatient (ED/IP) admission, number of clinic visits per year, and physician time spent per visit.
Research design and methods:
A cross-sectional historical cohort analysis was conducted by using the nationally representative Centers for Disease Control and Prevention National Ambulatory Medical Care Survey data from 2007 to 2013, including patients age ≥18 years with diabetes and either DFIs or DFUs. Study outcomes were analyzed by using generalized linear models controlling for key demographics and chronic conditions.
Results:
Across the estimated 5.6 billion ambulatory care visits between 2007 and 2013, 784.8 million involved diabetes and ∼6.7 million (0.8%) were for DFUs (0.3%) or DFIs (0.5%). Relative to other ambulatory clinical cases, multivariable analyses indicated that DFUs were associated with a 3.4 times higher odds of direct ED/IP admission (CI 1.01-11.28; P = 0.049), 2.1 times higher odds of referral to another physician (CI 1.14-3.71; P = 0.017), 1.9 times more visits in the past 12 months (CI 1.41-2.42; P < 0.001), and 1.4 times longer time spent per visit with the physician (CI 1.03-1.87; P = 0.033). DFIs were independently associated with a 6.7 times higher odds of direct ED referral or IP admission (CI 2.25-19.51; P < 0.001) and 1.5 times more visits in the past 12 months (CI 1.14-1.90; P = 0.003).
Conclusions:
This investigation of an estimated 6.7 million diabetic foot cases indicates markedly greater risks for both ED/IP admissions and number of outpatient visits, with DFUs also associated with a higher odds of referrals to other physicians and longer physician visit times.
Diabetic foot ulceration poses a heavy burden on the patient and the health care system, but prevention thereof receives little attention. For every euro spent on ulcer prevention, ten are spent on ulcer healing, and for every randomized controlled trial conducted on prevention, ten are conducted on healing. In this paper, we argue that a shift in priorities is needed. For the prevention of a first foot ulcer, we need more insight into the effect of interventions and practices already applied globally in many settings. This requires systematic recording of interventions and outcomes, and well-designed randomised controlled trials, which include analysis of cost-effectiveness. After healing of a foot ulcer, the risk of recurrence is high. For the prevention of a recurrent foot ulcer, home monitoring of foot temperature, pressure-relieving therapeutic footwear, and certain surgical interventions prove to be effective. The median effect size found in a total 23 studies on these interventions is large, over 60%, and further increases when patients are adherent to treatment. These interventions should be investigated for efficacy as a state-of-the-art integrated foot care approach, where attempts are made to assure treatment adherence. Effect sizes of 75-80% may be expected. If such state-of-the-art integrated foot care is implemented, the majority of problems with foot ulcer recurrence in diabetes can be resolved. It is therefore time to act and to set a new target in diabetic foot care. This target is to reduce foot ulcer incidence with at least 75%. This article is protected by copyright. All rights reserved.
Annual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence.
We undertook a systematic review of individual patient data (IPD) to identify the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes.
Studies were identified from searches of MEDLINE and EMBASE.
The electronic search strategies for MEDLINE and EMBASE databases created during an aggregate systematic review of predictive factors for foot ulceration in diabetes were updated and rerun to January 2013. One reviewer applied the IPD review eligibility criteria to the full-text articles of the studies identified in our literature search and also to all studies excluded from our aggregate systematic review to ensure that we did not miss eligible IPD. A second reviewer applied the eligibility criteria to a 10% random sample of the abstract search yield to check that no relevant material was missed. This review includes exposure variables (risk factors) only from individuals who were free of foot ulceration at the time of study entry and who had a diagnosis of diabetes mellitus (either type 1 or type 2). The outcome variable was incident ulceration.
Our search identified 16 cohort studies and we obtained anonymised IPD for 10. These data were collected from more than 16,000 people with diabetes worldwide and reanalysed by us. One data set was kept for independent validation. The data sets contributing IPD covered a range of temporal, geographical and clinical settings. We therefore selected random-effects meta-analysis, which assumes not that all the estimates from each study are estimates of the same underlying true value, but rather that the estimates belong to the same distribution. We selected candidate variables for meta-analysis using specific criteria. After univariate meta-analyses, the most clinically important predictors were identified by an international steering committee for inclusion in the primary, multivariable meta-analysis. Age, sex, duration of diabetes, monofilaments and pulses were considered most prognostically important. Meta-analyses based on data from the entire IPD population found that an inability to feel a 10-g monofilament [odds ratio (OR) 3.184, 95% confidence interval (CI) 2.654 to 3.82], at least one absent pedal pulse (OR 1.968, 95% CI 1.624 to 2.386), a longer duration of a diagnosis of diabetes (OR 1.024, 95% CI 1.011 to 1.036) and a previous history of ulceration (OR 6.589, 95% CI 2.488 to 17.45) were all predictive of risk. Female sex was protective (OR 0.743, 95% CI 0.598 to 0.922).
It was not possible to perform a meta-analysis using a one-step approach because we were unable to procure copies of one of the data sets and instead accessed data via Safe Haven.
The findings from this review identify risk assessment procedures that can reliably inform national and international diabetes clinical guideline foot risk assessment procedures. The evidence from a large sample of patients in worldwide settings show that the use of a 10-g monofilament or one absent pedal pulse will identify those at moderate or intermediate risk of foot ulceration, and a history of foot ulcers or lower-extremity amputation is sufficient to identify those at high risk. We propose the development of a clinical prediction rule (CPR) from our existing model using the following predictor variables: insensitivity to a 10-g monofilament, absent pedal pulses and a history of ulceration or lower-extremities amputations. This CPR could replace the many tests, signs and symptoms that patients currently have measured using equipment that is either costly or difficult to use.
This study is registered as PROSPERO CRD42011001841.
The National Institute for Health Research Health Technology Assessment programme.
This study was designed to explore whether participant-driven patient education in group sessions, compared to provision of standard information, will contribute to a statistically significant reduction in new ulceration during 24 months in patients with diabetes and high risk of ulceration. This is an interim analysis after six months.
A randomised controlled study was designed in accordance with CONSORT criteria. Inclusion criteria were: age 35–79 years old, diabetes mellitus, sensory neuropathy, and healed foot ulcer below the ankle; 657 patients (both male and female) were consecutively screened.
A total of 131 patients (35 women) were included in the study. Interim analysis of 98 patients after six months was done due to concerns about the patients' ability to fulfil the study per protocol. After a six-month follow up, 42% had developed a new foot ulcer and there was no statistical difference between the two groups. The number of patients was too small to draw any statistical conclusion regarding the effect of the intervention. At six months, five patients had died, and 21 had declined further participation or were lost to follow up. The main reasons for ulcer development were plantar stress ulcer and external trauma.
It was concluded that patients with diabetes and a healed foot ulcer develop foot ulcers in spite of participant-driven group education as this high risk patient group has external risk factors that are beyond this form of education. The educational method should be evaluated in patients with lower risk of ulceration. Copyright © 2011 FEND. Published by John Wiley & Sons, Ltd.
OBJECTIVE
To assess the efficacy of in-shoe orthoses designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration.RESEARCH DESIGN AND METHODS
Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion), or to study termination. Proportional hazards regression was used for analysis.RESULTSThere was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study.CONCLUSIONS
We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses but they did not significantly reduce nonulcerative lesions.
OBJECTIVE
Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention.RESEARCH DESIGN AND METHODS
As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence.RESULTSA total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98-27.57]), day-to-day variation in stride count (0.93 [0.89-0.99]), and cumulative duration of past foot ulcers (1.03 [1.00-1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01-23.96]), in-shoe peak pressure <200 kPa with footwear adherence >80% (0.43 [0.20-0.94]), barefoot peak pressure (1.11 [1.00-1.22]), and day-to-day variation in stride count (0.91 [0.86-0.96]).CONCLUSIONS
The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention.
Most cases of lower extremity limb loss in the United States occur among people with diabetes who have a diabetic foot ulcer (DFU). These DFUs and the associated limb loss that may occur lead to excess healthcare costs and have a large negative impact on mobility, psychosocial well-being, and quality of life. The strategies for DFU prevention and management are evolving, but the implementation of these prevention and management strategies remains challenging. Barriers to implementation include poor access to primary medical care; patient beliefs and lack of adherence to medical advice; delays in DFU recognition; limited healthcare resources and practice heterogeneity of specialists. Herein, we review the contemporary outcomes of DFU prevention and management to provide a framework for prioritizing quality improvement efforts within a resource-limited healthcare environment.
OBJECTIVE
Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence.RESEARCH DESIGN AND METHODS
We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken.RESULTSOn the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045).CONCLUSIONS
Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.
Critical limb ischemia, first defined in 1982, was intended to delineate a subgroup of patients with a threatened lower extremity primarily because of chronic ischemia. It was the intent of the original authors that patients with diabetes be excluded or analyzed separately. The Fontaine and Rutherford Systems have been used to classify risk of amputation and likelihood of benefit from revascularization by subcategorizing patients into two groups: ischemic rest pain and tissue loss. Due to demographic shifts over the last 40 years, especially a dramatic rise in the incidence of diabetes mellitus and rapidly expanding techniques of revascularization, it has become increasingly difficult to perform meaningful outcomes analysis for patients with threatened limbs using these existing classification systems. Particularly in patients with diabetes, limb threat is part of a broad disease spectrum. Perfusion is only one determinant of outcome; wound extent and the presence and severity of infection also greatly impact the threat to a limb. Therefore, the Society for Vascular Surgery Lower Extremity Guidelines Committee undertook the task of creating a new classification of the threatened lower extremity that reflects these important considerations. We term this new framework, the Society for Vascular Surgery Lower Extremity Threatened Limb Classification System. Risk stratification is based on three major factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). The implementation of this classification system is intended to permit more meaningful analysis of outcomes for various forms of therapy in this challenging, but heterogeneous population.
Because neuroischemic complications are associated with a high rate of recurrence, we propose a slight shift in the mechanism by which we counsel and communicate risk daily with our patients. If the epidemiology of this problem is comparable with that of cancer, and recurrences are common, then perhaps language commensurate with such risks should follow. After initial healing of an index wound, our unit now refers to patients not as being cured but rather as being "in remission." This concept is easy for the patient and the rest of the team to understand. We believe that it powerfully connotes the necessity for frequent follow-up and rapid intervention for inevitable minor and sometimes major complications.
To evaluate the safety and efficacy of the pan metatarsal head resection (PMHR) compared with nonsurgical management of wounds in the forefoot in people with diabetes.
The authors evaluated 92 patients with diabetes (66.3% male), with ulcers classified as University of Texas grade 1A or 2A at the plantar aspect of the forefoot using a case-control model. Cases were patients treated with multiple metatarsal head resections for multiple metatarsal head wounds, and controls received standard nonsurgical care. Both groups received standard off-loading and wound care. Outcomes included time to healing, reulceration, infection, and amputation.
Patients in the surgery group (SG) healed significantly faster than those in the standard therapy group (ST; 84.2 ± 39.9 days for the ST vs 60.1 ± 27.9 days for the SG; P = .003) and had fewer recurrent ulcers (39.1% for the ST vs 15.2% for the SG; P = .02; odds ratio [OR] = 3.6; 95% confidence interval [CI] = 1.3-9.7) and infections during 1 year of follow-up (64.5% for the ST vs 35.5% for the SG; P = .047; OR = 2.4; 95% CI = 1.0-6.0). There was no significant difference in the proportion of patients receiving an incident amputation in the follow-up period (13.0% for the ST vs 6.5% for the SG; P = .5).
The results of this study suggest that the PMHR may be associated with shorter times to healing and lower morbidity compared with standard care alone in patients without digital gangrene and with multiple plantar forefoot ulcers.
Few studies have examined factors associated with diabetic foot ulcer (DFU) recurrence. Using data from patients enrolled in the prospective Eurodiale DFU study, we investigated the frequency of, and risk factors for, DFU recurrence after healing during 3-year follow-up period. At our site, 93 Eurodiale enrolled patients had a healed DFU. Among these, 14 died; of the remaining 79 patients we enrolled 73 in this study. On entry to the Eurodiale study we assessed: demographic factors (age, sex, distance from hospital); diabetes-related factors (duration, HbA1c levels); comorbidities (obesity, renal failure, smoking, alcohol abuse); and DFU-related factors (peripheral arterial disease, ulcer infection, c-reactive protein [CRP]; foot deformities). During the 3-year follow-up, a DFU recurred in 42 patients (57·5%). By stepwise logistic regression of findings at initial DFU presentation, the significant independent predictors for recurrence were plantar ulcer location (odds ratio [OR] 8·62, 95% CI 2·2-33·2); presence of osteomyelitis (OR 5·17, 95% CI 1·4-18·7); HbA1c > 7·5% ([DCCT], OR 4·07, 95% CI 1·1-15·6); and CRP > 5 mg/l (OR 4·27, 95% CI 1·2-15·7). In these patients with a healed DFU, the majority had a recurrence of DFU during a 3-year follow-up, despite intensive foot care. The findings present at diagnosis of the initial DFU that were independent risk factors associated with ulcer recurrence (plantar location, bone infection, poor diabetes control and elevated CRP) appear to define those at high risk for recurrence, but may be amenable to targeted interventions.
Context:
Among persons diagnosed as having diabetes mellitus, the prevalence of foot ulcers is 4% to 10%, the annual population-based incidence is 1.0% to 4.1%, and the lifetime incidence may be as high as 25%. These ulcers frequently become infected, cause great morbidity, engender considerable financial costs, and are the usual first step to lower extremity amputation.
Objective:
To systematically review the evidence on the efficacy of methods advocated for preventing diabetic foot ulcers in the primary care setting.
Data sources, study selection, and data extraction:
The EBSCO, MEDLINE, and the National Guideline Clearinghouse databases were searched for articles published between January 1980 and April 2004 using database-specific keywords. Bibliographies of retrieved articles were also searched, along with the Cochrane Library and relevant Web sites. We reviewed the retrieved literature for pertinent information, paying particular attention to prospective cohort studies and randomized clinical trials.
Data synthesis:
Prevention of diabetic foot ulcers begins with screening for loss of protective sensation, which is best accomplished in the primary care setting with a brief history and the Semmes-Weinstein monofilament. Specialist clinics may quantify neuropathy with biothesiometry, measure plantar foot pressure, and assess lower extremity vascular status with Doppler ultrasound and ankle-brachial blood pressure indices. These measurements, in conjunction with other findings from the history and physical examination, enable clinicians to stratify patients based on risk and to determine the type of intervention. Educating patients about proper foot care and periodic foot examinations are effective interventions to prevent ulceration. Other possibly effective clinical interventions include optimizing glycemic control, smoking cessation, intensive podiatric care, debridement of calluses, and certain types of prophylactic foot surgery. The value of various types of prescription footwear for ulcer prevention is not clear.
Conclusions:
Substantial evidence supports screening all patients with diabetes to identify those at risk for foot ulceration. These patients might benefit from certain prophylactic interventions, including patient education, prescription footwear, intensive podiatric care, and evaluation for surgical interventions.
Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012 a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 - June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 papers were eligible for full text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients. This article is protected by copyright. All rights reserved.
In 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs; at least 33% of these costs were linked to the treatment of foot ulcers. Although the team approach to diabetic foot problems is effective in preventing lower extremity amputations, the costs associated with implementing a diabetic foot care team are not well understood. An analysis of these costs provides the basis for this report.
Diabetic foot problems impose a major economic burden, and costs increase disproportionately to the severity of the condition. Compared with diabetic patients without foot ulcers, the cost of care for patients with a foot ulcer is 5.4 times higher in the year after the first ulcer episode and 2.8 times higher in the second year. Costs for the treatment of the highest-grade ulcers are 8 times higher than for treating low-grade ulcers. Patients with diabetic foot ulcers require more frequent emergency department visits, are more commonly admitted to hospital, and require longer length of stays. Implementation of the team approach to manage diabetic foot ulcers within a given region or health care system has been reported to reduce long-term amputation rates from 82% to 62%. Limb salvage efforts may include aggressive therapy, such as revascularization procedures and advanced wound healing modalities. Although these procedures are costly, the team approach gradually leads to improved screening and prevention programs and earlier interventions, and thus seems to reduce long-term costs.
To date, aggressive limb preservation management for patients with diabetic foot ulcers has not usually been paired with adequate reimbursement. It is essential to direct efforts in patient-caregiver education to allow early recognition and management of all diabetic foot problems and to build integrated pathways of care that facilitate timely access to limb salvage procedures. Increasing evidence suggests that the costs for implementing diabetic foot teams can be offset over the long-term by improved access to care and reductions in foot complications and in amputation rates.
Therapeutic footwear for diabetic foot patients aims to reduce the risk of ulceration by relieving mechanical pressure on the foot. However, footwear efficacy is generally not assessed in clinical practice. The purpose of this study was to assess the value of in-shoe plantar pressure analysis to evaluate and optimize the pressure-reducing effects of diabetic therapeutic footwear.
Dynamic in-shoe plantar pressure distribution was measured in 23 neuropathic diabetic foot patients wearing fully customized footwear. Regions of interest (with peak pressure>200 kPa) were selected and targeted for pressure optimization by modifying the shoe or insole. After each of a maximum of three rounds of modifications, the effect on in-shoe plantar pressure was measured. Successful optimization was achieved with a peak pressure reduction of >25% (criterion A) or below an absolute level of 200 kPa (criterion B).
In 35 defined regions, mean peak pressure was significantly reduced from 303 (SD 77) to 208 (46) kPa after an average 1.6 rounds of footwear modifications (P<0.001). This result constitutes a 30.2% pressure relief (range 18-50% across regions). All regions were successfully optimized: 16 according to criterion A, 7 to criterion B, and 12 to criterion A and B. Footwear optimization lasted on average 53 min.
These findings suggest that in-shoe plantar pressure analysis is an effective and efficient tool to evaluate and guide footwear modifications that significantly reduce pressure in the neuropathic diabetic foot. This result provides an objective approach to instantly improve footwear quality, which should reduce the risk for pressure-related plantar foot ulcers.
To identify factors that influence survival after diabetes-related amputations.
We abstracted medical records of 1,043 hospitalized subjects with diabetes and a lower-extremity amputation from 1 January to 31 December 1993 in six metropolitan statistical areas in south Texas. We identified mortality in the 10-year period after amputation from death certificate data. Diabetes was verified using World Health Organization criteria. Amputations were identified by ICD-9-CM codes 84.11-84.18 and categorized as foot, below-knee amputation, and above-knee amputation and verified by reviewing medical records. We evaluated three levels of renal function: chronic kidney disease (CKD), hemodialysis, and no renal disease. We defined CKD based on a glomerular filtration rate<60 ml/min and hemodialysis from Current Procedural Terminology (CPT) codes (90921, 90925, 90935, and 90937). We used χ2 for trend and Cox regression analysis to evaluate risk factors for survival after amputation.
Patients with CKD and dialysis had more below-knee amputations and above-knee amputations than patients with no renal disease (P<0.01). Survival was significantly higher in patients with no renal impairment (P<0.01). The Cox regression indicated a 290% increase in hazard for death for dialysis treatment (hazard ratio [HR] 3.9, 95% CI 3.07-5.0) and a 46% increase for CKD (HR 1.46, 95% CI 1.21-1.77). Subjects with an above-knee amputation had a 167% increase in hazard (HR 2.67, 95% CI 2.14-3.34), and below-knee amputation patients had a 67% increase in hazard for death.
Survival after amputation is lower in diabetic patients with CKD, dialysis, and high-level amputations.
To evaluate the frequency of foot prevention strategies among high-risk patients with diabetes.
Electronic medical records were used to identify 150 patients on dialysis and 150 patients with previous foot ulceration or amputation with 30 months follow-up to determine the frequency with which patients received education, podiatry care, and therapeutic shoes and insoles as prevention services.
Few patients had formal education (1.3%), therapeutic shoes/insoles (7%), or preventative podiatric care (30%). The ulcer incidence density was the same in both groups (210 per 1,000 person-years). In contrast, the amputation incidence density was higher in the dialysis group compared with the ulcer group (58.7 vs. 13.1 per 1,000 person-years, P < 0.001). Patients on dialysis were younger and more likely to be of non-Hispanic white descent (P = 0.006) than patients with a previous history of ulcer or amputation.
Prevention services are infrequently provided to high-risk patients.
To compare mortality rates for individuals with diabetes with and without a history of foot ulcer (HFU) and with that for the nondiabetic population.
This population-based study included 155 diabetic individuals with an HFU, 1,339 diabetic individuals without an HFU, and 63,632 nondiabetic individuals who were all followed for 10 years with mortality as the end point.
During the follow-up period, a total of 49.0% of diabetic individuals with an HFU died, compared with 35.2% of diabetic individuals without an HFU and 10.5% of those without diabetes. In Cox regression analyses adjusted for age, sex, education, current smoking, and waist circumference, having an HFU was associated with more than a twofold (2.29 [95% CI 1.82-2.88]) hazard risk for mortality compared with that of the nondiabetic group. In corresponding analyses comparing diabetic individuals with and without an HFU, an HFU was associated with 47% increased mortality (1.47 [1.14-1.89]). Significant covariates were older age, male sex, and current smoking. After inclusion of A1C, insulin use, microalbuminuria, cardiovascular disease, and depression scores in the model, each was significantly related to life expectancy.
AN HFU increased mortality risk among community-dwelling adults and elderly individuals with diabetes. The excess risk persisted after adjustment for comorbidity and depression scores, indicating that close clinical monitoring might be warranted among individuals with an HFU, who may be particularly vulnerable to adverse outcomes.
To study whether there is an association between cognitive impairment and the relapse rate of foot ulcers in diabetic patients and those with previous foot ulcers.
This single-center prospective study assessed the association of cognitive function and risk for ulcer relapse in 59 patients with diabetes (mean age 65.1 years, diabetes duration 16.5 years, and A1C 7.4%), peripheral neuropathy, and a history of foot ulceration. Premorbid and current cognitive functions were measured (multiple-choice vocabulary test [Lehrl], number-symbol test, mosaic test [HAWIE-R], and trail-making tests A and B [Reitan]). Prevalence of depression was evaluated retrospectively (diagnoses in patient files or use of antidepressive medication). Patients were re-examined after 1 year.
Three patients (5%) died during follow-up (one of sepsis and two of heart problems). The remaining 56 patients (48%) developed 27 new foot ulcerations (78% superficial ulcerations [Wagner stage 1]). Characteristics of patients with and without ulcer relapse were not different. In a binary logistic regression analysis, cognitive function is not predictive of foot reulceration.
Cognitive function is not an important determinant of foot reulceration.
This observer-blind, randomised controlled trial was designed to determine the effect of a foot care education programme in the secondary prevention of foot ulcers.
People with newly healed foot ulcers attending one of three specialist clinics were allocated to receive either targeted, one-to-one education or usual care, using a computer-generated random allocation sequence that had been prepared in advance but which was concealed from the clinical researcher. The primary outcome was ulcer incidence at 12 months. Secondary outcomes were ulcer incidence at 6 months and incidence of amputation, mood (Hospital Anxiety and Depression Scale) and quality of life (Diabetic Foot Ulcer Scale) at 6 and 12 months. Protective foot care behaviours (Nottingham Assessment of Functional Footcare) were assessed at 12 months.
There were 87 (mean [SD] age 63.5 [12.1] years) patients in the intervention group and 85 control patients (mean [SD] age 64.9 [10.9] years). The groups were comparable at baseline. No significant differences (p > 0.05) were observed between groups in ulcer incidence at either 6 months (intervention 30%, control 21%) or 12 months (intervention 41%, control 41%). Recommended foot care behaviours at 12 months were better in the intervention than in the control group (p = 0.03), but education had no significant (p > 0.05) effect on mood, quality of life or amputations.
Even though the intervention was associated with improved foot care behaviour, there was no evidence that this programme of targeted education was associated with clinical benefit in this population when compared with usual care. The usefulness and optimal delivery of education to such a high-risk group requires further evaluation.
ClinicalTrials.gov NCT00729456 Funding: Diabetes UK project grant RD02/0002535.
Objective:
We conducted a multicenter evaluation of a novel remote foot-temperature monitoring system to characterize its accuracy for predicting impending diabetic foot ulcers (DFU) in a cohort of patients with diabetes with previously healed DFU.
Research design and methods:
We enrolled 132 participants with diabetes and prior DFU in this 34-week cohort study to evaluate a remote foot-temperature monitoring system (ClinicalTrials.gov Identifier NCT02647346). The study device was a wireless daily-use thermometric foot mat to assess plantar temperature asymmetries. The primary outcome of interest was development of nonacute plantar DFU, and the primary efficacy analysis was the accuracy of the study device for predicting the occurrence of DFU over several temperature asymmetry thresholds.
Results:
Of the 129 participants who contributed evaluable data to the study, a total of 37 (28.7%) presented with 53 DFU (0.62 DFU/participant/year). At an asymmetry of 2.22°C, the standard threshold used in previous studies, the system correctly identified 97% of observed DFU, with an average lead time of 37 days and a false-positive rate of 57%. Increasing the temperature threshold to 3.20°C decreased sensitivity to 70% but similarly reduced the false-positive rate to 32% with the same lead time of 37 days. Approximately 86% of the cohort used the system at least 3 days a week on average over the study.
Conclusions:
Given the encouraging study results and the significant burden of DFU, use of this mat may result in significant reductions in morbidity, mortality, and resource utilization.
Diabetic foot is a severe public health issue, yet rare studies investigated its global epidemiology. Here we performed a systematic review and meta-analysis through searching PubMed, EMBASE, ISI Web of science, and Cochrane database. We found that that global diabetic foot ulcer prevalence was 6.3% (95%CI: 5.4–7.3%), which was higher in males (4.5%, 95%CI: 3.7–5.2%) than in females (3.5%, 95%CI: 2.8–4.2%), and higher in type 2 diabetic patients (6.4%, 95%CI: 4.6–8.1%) than in type 1 diabetics (5.5%, 95%CI: 3.2–7.7%). North America had the highest prevalence (13.0%, 95%CI: 10.0–15.9%), Oceania had the lowest (3.0%, 95% CI: 0.9–5.0%), and the prevalence in Asia, Europe, and Africa were 5.5% (95%CI: 4.6–6.4%), 5.1% (95%CI: 4.1–6.0%), and 7.2% (95%CI: 5.1–9.3%), respectively. Australia has the lowest (1.5%, 95%CI: 0.7–2.4%) and Belgium has the highest prevalence (16.6%, 95%CI: 10.7–22.4%), followed by Canada (14.8%, 95%CI: 9.4–20.1%) and USA (13.0%, 95%CI: 8.3–17.7%). The patients with diabetic foot ulcer were older, had a lower body mass index, longer diabetic duration, and had more hypertension, diabetic retinopathy, and smoking history than patients without diabetic foot ulceration. Our results provide suggestions for policy makers in deciding preventing strategy of diabetic foot ulceration in the future.
• Key messages
• Global prevalence of diabetic foot is 6.3% (95%CI: 5.4–7.3%), and the prevalence in North America, Asia, Europe, Africa and Oceania was 13.0% (95%CI: 10.0–15.9%), 5.5% (95%CI: 4.6–6.4%), 5.1% (95%CI: 4.1–6.0%), 7.2% (95%CI: 5.1–9.3%), and 3.0% (95% CI: 0.9–5.0%).
• Diabetic foot was more prevalent in males than in females, and more prevalent in type 2 diabetic foot patients than in type 1 diabetic foot patients.
• The patients with diabetic foot were older, had a lower body mass index, longer diabetic duration, and had more hypertension, diabetic retinopathy, and smoking history than patients without diabetic foot.
Background:
An increased plantar pressure is a causative factor in the development of plantar foot ulcers in people with diabetes mellitus, and ulcers are a precursor of lower extremity amputation.
Methods:
In this article, the evidence is reviewed that relieving areas of increased plantar pressure (ie, offloading) can heal plantar foot ulcers and prevent their recurrence.
Results:
Noninfected, nonischemic neuropathic plantar forefoot ulcers should heal in 6 to 8 weeks with adequate offloading. Recent meta-analyses and systematic reviews show that nonremovable knee-high devices are most effective. This is probably because they eliminate the problem of nonadherence with the use of a removable device. Studies show a large discrepancy between evidence-based recommendations on offloading and what is used in clinical practice. Many clinics continue to use methods that are less effective or have not been proven to be effective, while ignoring evidence-based methods. Strategies are proposed to address this issue, notably the adoption and implementation of recent international guidelines by professional societies and a stronger focus of clinicians on expedited healing. For the prevention of plantar foot ulcer recurrence in high-risk patients, 2 recent trials have shown that the incidence of recurrence can be significantly reduced with custom-made footwear that has a demonstrated pressure-relieving effect through guidance by plantar pressure measurements, under the condition that the footwear is worn.
Conclusion:
This review helps to inform clinicians about effective offloading treatment for healing plantar foot ulcers and preventing their recurrence.
Objectives:
Patients presenting to a public hospital with critical limb ischemia (CLI) typically have advanced disease with significant co-morbidities. The purpose of this study was to assess the influence of revascularization on one year amputation rate of CLI patients presenting to Los Angeles County USC Medical Center, classified according to the SVS WIfI.
Methods:
A retrospective review of patients who presented to a public hospital with CLI from February 2010 to July 2014 was performed. Patients were classified according to the WIfI system. Only patients with complete data who survived at least 12 months after presentation were included.
Results:
93 patients with 98 affected limbs were included. The mean age was 62.8. 82 (84%) had hypertension and 71 (72%) had diabetes. 50 (57.5%) limbs had Trans-Atlantic Inter-Society Consensus (TASC) C or D femoral-popliteal lesions and 82 (98%) had significant infra-popliteal disease. The majority had moderate or high WIfI amputation and revascularization scores. 84 (86%) limbs underwent open, endovascular or hybrid revascularization. Overall OYMA rate was 26.5%. In limbs with high WIfI amputation score, the OYMA was 34.5%: 21.4% in those who were revascularized and 57% in those who weren't. On univariable analysis, factors associated with increased risk of OYMA were: non-revascularization (P=0.005), hyperlipidemia (P=0.06), hemodialysis (P= 0.005), gangrene (P=0.02), ulcer classification (P=0.05), WIfI amputation score (P=0.026) and WIfI wound grade (P=0.04). On multivariable analysis, increasing WIfI amputation score (OR 1.84, 95% CI 1.0-3.39) was associated with increased risk of OYMA while revascularization (OR 0.24, 95% CI 0.07-0.80) was associated with decreased risk of OYMA.
Conclusions:
The OYMA rates in this population were consistent with those predicted by the WIfI classification system. In this population, revascularization significantly reduced the risk of amputation. Co-morbidities, including DM and TASC classification did not moderate the association of WIfI amputation score with risk of one-year major amputation.
Custom-molded orthotic devices with soft insoles are thought to reduce recurrence after healing of diabetic foot lesions. The aim of the study was to investigate the influence of specially made shoes on the incidence of foot lesions after healing of a previous lesion and patient's discharge from hospital. Study design: 46 patients (age: 66,18 years (mean)) were examined 25,49 months (mean) after discharge from hospital. Group A (24 patients) used their orthotic device regularly, group B (22 patients) used regular shoes. Results: Incidence of recurrence of foot lesions was 37,5% for 2 years. Recurrence of foot lesions occurred in 10 patients of group A (41,7%) and in 8 patients of group B (36,4%). There was no amputation in group A and 2 amputations in group B (ray amputation in one case and a below the knee amputation in the other). Conclusions: Custom-molded orthotic devices do not necessarily reduce recurrences of diabetic foot lesions.
Aims:
The presence of diabetic foot ulcers is strongly associated with an increased risk of death. In this study, we investigate whether the effects of diabetes-associated complications can explain the apparent relationship between diabetic foot ulcers and death.
Methods:
We analysed data from 414 523 people with diabetes enrolled in practices associated with The Health Improvement Network in the United Kingdom. Our methods were designed to control for potential confounders in order to isolate the relationship between diabetic foot ulcers and death. Using proportional hazards models and the area under the receiver operator curve, we evaluated the effects of diabetic foot ulcers and the covariates on death.
Results:
Among the patients, 20 737 developed diabetic foot ulcers; 5.0% of people with new ulcers died within 12 months of their first foot ulcer visit and 42.2% of people with foot ulcers died within 5 years. After controlling for major known complications of diabetes that might influence mortality, the correlation between diabetic foot ulcers and death remained strong with a fully adjusted hazard ratio of 2.48 (95% confidence interval: 2.43, 2.54). Geographic variance existed but was not spatially associated.
Conclusions:
Diabetic foot ulcers are linked to an increased risk of death. This cannot be explained by other common risk factors. These results suggest that either there are major unknown risk factors associated with both diabetic foot ulcers and death, or that diabetic foot ulceration itself is a serious threat, which seems unlikely. A diabetic foot ulcer should be seen as a major warning sign for mortality, necessitating closer medical follow-up. This article is protected by copyright. All rights reserved.
The International Working Group on the Diabetic Foot (IWGDF) recommends that auditing should be part of the organization of diabetic foot care; the efforts required for data collection and analysis being balanced by the expected benefits. In Germany legislature demands measures of quality management for in- and out-patient facilities and, in 2003, the Germany Working Group on the Diabetic Foot defined and developed a certification procedure for diabetic foot centers to be recognized as "specialized". This includes a description of management facilities, treatment procedures and outcomes, as well as the organization of mutual auditing visits between the centers. Outcome data is collected at baseline and 6- months on 30 consecutive patients. By 2014 almost 24.000 cases had been collected and analysed. Since 2005 Belgian multidisciplinary diabetic foot clinics could apply for recognition by health authorities. For continued recognition diabetic foot clinics need to treat at least 52 patients with a new foot problem (Wagner 2 or more or active Charcot foot) per annum. Baseline and 6-months outcome data of these patients are included in an audit-feedback initiative. Although originally fully independent of each other, the common goal of these two initiatives is quality improvement of national diabetic foot care and hence exchanges between systems has commenced. In future, the German and Belgian accreditation models might serve as templates for comparable initiatives in other countries. Just recently the IWGDF initiated a working group for further discussion of accreditation and auditing models (IWGDF AB(B)A Working Group).
Background:
Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at risk for ulceration.
Methods:
The available medical scientific literature in PubMed, EMBASE, CINAHL and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers.
Results:
From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small.
Conclusion:
The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions and is practically nonexistent for the prevention of a first foot ulcer and non-plantar foot ulcer.
Recommendations
To identify a person with diabetes at risk for foot ulceration, examine the feet annually to seek evidence for signs or symptoms of peripheral neuropathy and peripheral artery disease. (GRADE strength of recommendation: strong; Quality of evidence: low)
In a person with diabetes who has peripheral neuropathy, screen for a history of foot ulceration or lower‐extremity amputation, peripheral artery disease, foot deformity, pre‐ulcerative signs on the foot, poor foot hygiene and ill‐fitting or inadequate footwear. (Strong; Low)
Treat any pre‐ulcerative sign on the foot of a patient with diabetes. This includes removing callus, protecting blisters and draining when necessary, treating ingrown or thickened toe nails, treating haemorrhage when necessary and prescribing antifungal treatment for fungal infections. (Strong; Low)
To protect their feet, instruct an at‐risk patient with diabetes not to walk barefoot, in socks only, or in thin‐soled standard slippers, whether at home or when outside. (Strong; Low)
Instruct an at‐risk patient with diabetes to daily inspect their feet and the inside of their shoes, daily wash their feet (with careful drying particularly between the toes), avoid using chemical agents or plasters to remove callus or corns, use emollients to lubricate dry skin and cut toe nails straight across. (Weak; Low)
Instruct an at‐risk patient with diabetes to wear properly fitting footwear to prevent a first foot ulcer, either plantar or non‐plantar, or a recurrent non‐plantar foot ulcer. When a foot deformity or a pre‐ulcerative sign is present, consider prescribing therapeutic shoes, custom‐made insoles or toe orthosis. (Strong; Low)
To prevent a recurrent plantar foot ulcer in an at‐risk patient with diabetes, prescribe therapeutic footwear that has a demonstrated plantar pressure‐relieving effect during walking (i.e. 30% relief compared with plantar pressure in standard of care therapeutic footwear) and encourage the patient to wear this footwear. (Strong; Moderate)
To prevent a first foot ulcer in an at‐risk patient with diabetes, provide education aimed at improving foot care knowledge and behaviour, as well as encouraging the patient to adhere to this foot care advice. (Weak; Low)
To prevent a recurrent foot ulcer in an at‐risk patient with diabetes, provide integrated foot care, which includes professional foot treatment, adequate footwear and education. This should be repeated or re‐evaluated once every 1 to 3 months as necessary. (Strong; Low)
Instruct a high‐risk patient with diabetes to monitor foot skin temperature at home to prevent a first or recurrent plantar foot ulcer. This aims at identifying the early signs of inflammation, followed by action taken by the patient and care provider to resolve the cause of inflammation. (Weak; Moderate)
Consider digital flexor tenotomy to prevent a toe ulcer when conservative treatment fails in a high‐risk patient with diabetes, hammertoes and either a pre‐ulcerative sign or an ulcer on the distal toe. (Weak; Low)
Consider Achilles tendon lengthening, joint arthroplasty, single or pan metatarsal head resection, or osteotomy to prevent a recurrent foot ulcer when conservative treatment fails in a high‐risk patient with diabetes and a plantar forefoot ulcer. (Weak; Low)
Do not use a nerve decompression procedure in an effort to prevent a foot ulcer in an at‐risk patient with diabetes, in preference to accepted standards of good quality care. (Weak; Low)
AimTo estimate the annual cost of diabetic foot care in a universal healthcare system.Methods
National datasets and economic modelling were used to estimate the cost of diabetic foot disease to the National Health Service in England in 2010–2011. The cost of hospital admissions specific to foot disease or amputation was estimated from Hospital Episode Statistics and national tariffs. Multivariate regression analysis was used to estimate the impact of foot disease on length of stay in other admissions. Costs in other areas were estimated from published studies and data from individual hospitals.ResultsThe cost of diabetic foot care in 2010–2011 is estimated at £580m, almost 0.6% of National Health Service expenditure in England. We estimate that more than half this sum (£307m) was spent on care for ulceration in primary and community settings. A total of 8.8% of hospital admissions with recorded diabetes included ulcer care or amputation. Regression analysis suggests that foot disease was associated with a 2.51-fold (95% CI 2.43–2.59) increase in length of stay.The cost of inpatient ulcer care is estimated at £219 m, and that of amputation care at £55 m.Conclusions
The cost of diabetic foot disease is substantial. Ignorance of the cost of current care may hinder commissioning of effective services for prevention and management in both community and secondary care.This article is protected by copyright. All rights reserved.
Le mal perforant plantaire est une complication classique et fréquente d’une pathologie élevée au rang de pandémie par l’OMS : le diabète. Bien que couramment rencontré dans la pratique médicale, le mal perforant reste mal compris dans sa physiopathologie. Son traitement est généralement long et décevant, se soldant trop souvent par une amputation. Paradoxalement, la littérature médicale est très pauvre, s’agissant des approches chirurgicales du mal perforant plantaire. En dehors des cas de lésions d’origine vasculaire qui nécessite surtout une technique de revascularisation, nous avons expérimenté une approche originale permettant le traitement chirurgical d’un mal perforant patent. Il s’agit de corriger l’architecture du pied afin de mieux répartir les points d’appui plantaires. Nous effectuons des ostéotomies de soustraction en amont du mal perforant afin de redresser l’axe osseux déformé. L’appui total est prescrit dès le lendemain de l’intervention dans la quasi-totalité des cas.