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Advantages of early diagnosis of diabetic neuropathy in the prevention of diabetic foot ulcers
Abstract
Aims:
to evaluate the utility of the sudomotor function test (SFT) as a clinical tool in the Risk Stratification System of diabetic patients and to demonstrate the earlier detection of the risk of developing diabetic foot ulcers (DFU) compared to the standard clinical tests.
Methods:
prospective follow-up study on 263 patients enrolled consecutively over 3.5 years. Diabetic patients without active DFU were classified according to the International Working Group Risk Stratification System (RSS) and categorized according to the results of the Semmes-Wenstein Monofilament (SWM) and biothesiometer measurements or the SFT. The main outcome evaluated was the development of DFU.
Results:
median follow-up was 42 [38-44] months. Sixty patients (22.8%) developed DFU after a median of 6.2 [3-17] months. Ten patients that were included in the no-risk group (group 0) based on the SWM and biothesiometer results developed DFU. Thus the sensitivity of this approach was 83.33% and the specificity was 50.47%. Based on the SFT results, all patients that developed DFU were included in the correct risk group. This approach had 100% sensitivity and 31.53% specificity. Regarding the diagnostic accuracy of the two Methods, the respective AUC values were 0.776 (95% CI 0.702-0.849) and 0.816 (95% CI 0.757-0.874).
Conclusions:
SFT improved RSS in diabetic patients in a specialized diabetic foot unit. SFT categorized patients correctly according to the risk of developing DFU.
... It is noteworthy that foot infections are highly common in patients with diabetes, which usually start after a foot wound that eventually leads to ulceration. In this respect, neuropathy seems to be an important component of foot ulceration which, in turn, increases the risk of amputation (34). The wound is predisposed to a loss of sensitivity because of the damage in neuron fibers by pathophysiological mechanisms not fully understood (34)(35)(36). ...
... In this respect, neuropathy seems to be an important component of foot ulceration which, in turn, increases the risk of amputation (34). The wound is predisposed to a loss of sensitivity because of the damage in neuron fibers by pathophysiological mechanisms not fully understood (34)(35)(36). It has been suggested that a vascular endothelium damage produced by inflammation and oxidative stress (36) may produce alterations in the microcirculation and, finally, nerve damage (37). ...
Uncontrolled diabetes results in several metabolic alterations including hyperglycemia. Indeed, several preclinical and clinical studies have suggested that this condition may induce susceptibility and the development of more aggressive infectious diseases, especially those caused by some bacteria (including Chlamydophila pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae, among others) and viruses [such as coronavirus 2 (CoV2), Influenza A virus, Hepatitis B, etc.]. Although the precise mechanisms that link glycemia to the exacerbated infections remain elusive, hyperglycemia is known to induce a wide array of changes in the immune system activity, including alterations in: (i) the microenvironment of immune cells (e.g., pH, blood viscosity and other biochemical parameters); (ii) the supply of energy to infectious bacteria; (iii) the inflammatory response; and (iv) oxidative stress as a result of bacterial proliferative metabolism. Consistent with this evidence, some bacterial infections are typical (and/or have a worse prognosis) in patients with hypercaloric diets and a stressful lifestyle (conditions that promote hyperglycemic episodes). On this basis, the present review is particularly focused on: (i) the role of diabetes in the development of some bacterial and viral infections by analyzing preclinical and clinical findings; (ii) discussing the possible mechanisms by which hyperglycemia may increase the susceptibility for developing infections; and (iii) further understanding the impact of hyperglycemia on the immune system.
... Another visual diagnosis is Charcot"s foot (diabetic neuronal-osteoarthropathy). Charcot"s foot is characterized by reactive hyperemia with significant swelling and destruction of osseous structure which consequently causes sintering of the metatarsus region ( Sanz et al.,2018 ). ...
This is a case-control study, including 120 individuals who were divided into
four groups: control group, diabetes mellitus without complication group, diabetic
foot ulcer group and (diabetic foot with chronic kidney disease) group .Procalcitonin, Cystatin C, Nephrin ,and Kidney injury molecule-1 were
determined by using the Enzyme-linked immunosorbent assay (ELISA) technique
while C-reactive protein(CRP) and HbA1C were determined by using immune
detection Method, Blood glucose, blood urea and serum creatinine were measured
using a colorimetric method.
... Moreover, those with autonomic neuropathy may also have significant hypoglycemic unawareness [48], where CGM can be particularly useful if they are on therapies that can result in low glucose levels. Individuals with neuropathy and foot ulcers can develop infective complications [49], which can increase glucose levels and where CGM can be useful to monitor and optimize glycemia, in turn helping with the infective episode and avoiding the need for surgical interventions, including amputation. ...
Continuous glucose monitoring (CGM) is now advocated for the clinical management of individuals with type 1 diabetes (T1D). However, this glucose monitoring strategy is not routinely used in type 2 diabetes (T2D), given the large population, significant cost implications and relatively limited supporting evidence. T2D is a more heterogenous condition compared with T1D with various glucose lowering therapies that do not necessarily require CGM to ensure within target glucose levels. While all individuals with T2D may benefit from CGM at certain time points, the whole T2D population does not necessarily require this technology continuously, which should be prioritized based on patient benefit and cost effectiveness. In this pragmatic opinion piece, we describe the rationale and evidence for CGM use in different subgroups of individuals with T2d, divided according to the stage of the condition, glycemic therapies, presence of diabetes complications, or associated co-morbidities. We discuss a total of 16 T2D subgroups and provide a clinical view on CGM use in each, based on current evidence while also highlighting areas of knowledge gaps. This work provides health care professionals with a simple guide to CGM use in different T2D groups and gives suggestion for future studies to justify expansion of this technology.
... However, complications were observed in 16.8% of patients, emphasizing the importance of ongoing monitoring and early intervention in this vulnerable population [12]. Adverse drug reactions, primarily gastrointestinal disturbances, were reported in 12.3% of cases, highlighting the need for vigilant surveillance of side effects, especially in patients with UDM [13]. Our analysis demonstrated a positive association between guideline-adherent antibiotic therapy and favorable treatment responses (OR = 2.14, p = 0.005). ...
... Diabetic foot ulcers refer to a terminal syndrome of diabetes that can be markedly lethal [24] . In the clinical setting, the medical diagnosis of diabetic foot ulcers routinely involves ulcerative determination, nervous system assessment, and vascular lesion test [25] . Common clinical practice for the treatment of diabetic foot ulcers includes control of blood sugar, suppression of infection, and supportive treatments for maintaining a stable internal environment [5] . ...
Background
In some developing countries, people have little knowledge about the causes of diabetic foot ulcers. Therefore, public health education for patients on these conditions is a prerequisite for effective pharmacological treatment. Diabetic foot ulcers are a complex symptom of diabetes and are hard to cure due to the lack of efficacious medicine and alternative treatment approaches. Vitamin A (VA) is known to have potent biological functions, including skin repair and immunoregulation. However, the potential pharmacological effects and molecular mechanisms of VA on foot ulcers are still to be discovered.
Methods
By using bioinformatic/computational analyses, including network pharmacology, gene ontology and the Kyoto Encyclopedia of Genes and Genomes enrichment analysis, we aimed to identify and reveal the pharmacological targets, molecular mechanisms, biological functions, and signaling pathways of VA in the treatment of diabetic foot ulcers.
Results
A total of 66 intersection genes were identified as candidate targets of VA, which are related to diabetic foot ulcers. Therein, 18 core genes/targets, namely JUN, MAPK1, THRB, MAPK14, MTNR1B, CXCR3, ESR1, AR, HDAC1, IL-10, CNR1, DRD2, EGFR, ADRA2A, CCND1, RXRB, RARA , and RXRA , were further identified. Furthermore, the biological processes, cell components, and molecular functions which may underlie the effects of VA against diabetic foot ulcers were characterized.
Conclusion
Based on our findings, we concluded that the pharmacological effects of VA on diabetic foot ulcers primarily involve the promotion of cellular regeneration and proliferation and the inhibition of inflammatory response. The core genes/targets may potentially serve as promising biomarkers for the diagnosis of diabetic foot ulcers.
... Presently, detection methods and diagnostic standards of DPN have not been unified, which affects clinical diagnosis and treatment. 4 Thus, it is necessary to find a simple, convenient, fast and reliable method for early diagnosis of DPN. Presently, the mechanism of DPN is not very clear. ...
Introduction
Early identification and treatment of diabetic peripheral neuropathy (DPN) are crucial. Presently, the mechanism of DPN is not very clear, and there are inconclusive conclusions about the influencing factors of vascular dynamic characteristics in DPN. This study aims to detect and compare the hemodynamic characteristics of plantar blood vessels in patients with mild DPN and healthy participants to explore a simple and reliable new idea and a potential method for early assessment of DPN and to investigate the influence of gender and age on hemodynamic characteristics.
Research design and methods
Sixty age-matched and gender-matched patients with mild DPN (30 men and 30 women) and 60 healthy participants were randomly recruited. Color Doppler ultrasound was used to measure and analyze the hemodynamic characteristics of plantar-related vessels.
Results
Ultrasonic measurements had good test–retest reliability. There may be no statistically significant differences in the blood flow velocity and blood flow in the plantar-related blood vessels of participants, irrespective of their gender and age. For patients with mild DPN, color Doppler ultrasound may indicate early hemodynamic abnormalities when there are no obvious abnormalities in the large arteries of the lower limbs, which are specifically manifested as increased blood flow velocity and blood flow in the distal small vessels.
Conclusions
Our study provides in vivo data support for the dynamic characteristics of the plantar blood vessel biomechanical model and provides a new idea of in vivo and non-invasive early diagnosis of DPN.
... Similarly, the Sudoscan® relies on sweating to measure skin conductance (Sanz-Corbalan et al., 2018). Compared to the 10g monofilament, Sanz-Corbalan et al., (2018) found the Sudoscan® demonstrated good sensitivity (100%) and accuracy (AUC = 0.82; 95% CI = 0.76-0.87), ...
NICE NG19 (2015) guides the early identification of neuroischaemia to help prevent diabetes foot complications, but these largely subjective assessments are not standardised. The aim of this doctoral thesis was to explore the concept that new technological devices (DPNCheck® and Medicap) could give a picture that is clearer and closer to that truth of underlying neuroischaemia, than existing NICE NG19 methods (10g monofilament and TBI). To achieve this, a series of cross-sectional observational investigations were undertaken to establish the reliability, validity and clinical effectiveness of the DPNCheck® against the 10g monofilament in the assessment of sensory neuropathy, and the Medicap against the TBI in the assessment of ischaemia, in adults with type 2 diabetes. Experimental Study 1 investigated DPNCheck® reliability in 21 healthy participants, and found ICC (2,1)velocity = 0.97 (95% CI = 0.91- 0.99), and ICC (2,1)amplitude between 0.76 – 0.96 (95% CI = 0.63 – 0.99). Medicap validity was investigated against a TCM400 amongst healthy (Experimental Study 2) and low risk diabetes (Experimental Study 3) participants. The Medicap demonstrated criterion validity, but overestimated TcPO2 by a mean of 24.8 (± 18.4) mmHg. Experimental Study 4 found TBI intrarater reliability ICC (2,2) ranging from 0.79 – 0.99 (SEM = 0.03; 95% CI; 0.68 – 0.99), and interrater reliability with ICC(2,2) between 0.81 – 0.98 (SEM 0.03; 95% CI; 0.65 – 0.99) ; and overall ICC (2,3) =0.96 (95% CI; 0.93 – 0.98). Experimental study 5 investigated the intrarater reliability of the TBI, DPNCheck®, Medicap and 10g monofilament in people with diabetes, and found ICC (3,1)TBI = 0.97 (95% CI = 0.84-0.99), and for ICC(3,1)DPNCheck® velocity and amplitude =0.96 ((95% CI = 0.87-0.99); ICC(3,1) Medicap = 0.66 (95% CI = 0.24 – 0.87), and ICC(3,1) 10g monofilament = 0.38 (95% CI = -0.08 – 0.73). In Experimental Study 6, from 92 participants with diabetes, the DPNCheck® suspected 45 participants of having neuropathy, against 21 by the 10g monofilament which had a false negative rate of 35.2%, a sensitivity of 44.4% (95% CI = 30.9 – 58.8%), specificity of 97.9% (95% CI = 88.9 -99.6%) and k=0.43 (95%C1:0.26 - 0.54; p < 0.001). In Experimental Study 7, both the TBI and Medicap each suspected 10 participants of ischaemia, but did not agree on any cases. Against the TBI, Medicap sensitivity was 0% (95% CI = 0 – 30.9%); specificity 86.6% (95% CI = 77.3- 93.1%), and - 0.12 (p = 0.24). The Medicap demonstrated criterion validity and fair reliability, whilst the DPNCheck® demonstrated and excellent reliability. The DPNCheck® was more effective at assessing sensory neuropathy than the 10g monofilament, whilst the Medicap and the TBI were poorly comparable in the assessment of ischaemia. Findings from these thesis investigations point to a new clinical paradigm for earlier detection of peripheral neuropathy in which the quality and quantity components of neuroischaemia assessment could be combined. The implications for this would be in the detection of neuropathy at the stage where interventions have the potential to change the course of tissue damage and thus prevent diabetes related foot ulceration and amputation.
... Peripheral neuropathy causes the skin's blood regulation and control of perspiration to weaken, resulting in decreased elasticity of the foot tissue, thereby increasing the incidence rate of ulcer. [21] In addition, the infection is the direct cause of amputation of DFU patients, due to peripheral neuropathy, the normal sweating ability of the sweat glands weakened, making it easier for bacteria to plant deep tissue. In addition, the inflammatory chemotaxis of DFU patients is weakened and the resistance is reduced. ...
Background:
Diabetic foot ulcer (DFU) is one of the serious complications of diabetes. It is the result of a joint effect of lower extremities vascular lesions, neuropathy, and infection, which require amputation and even threaten the life of the patient. At present, the conventional treatment for DFU includes infection control, wound care, wound reduction, reduction of foot pressure, use of dressings that are beneficial to wound surface healing, etc, but the effectiveness is not satisfactory. Recombinant human growth hormone and alginate dressing have been used in clinical, but there is lack of the relevant evidence of its effectiveness and safety, so this study evaluates the clinical effectiveness and safety of recombinant human growth hormone combined with alginate dressing in the treatment of DFU by systematic evaluation, the purpose is to provide a theoretical basis for the treatment of diabetic foot ulcer.
Methods:
This study mainly retrieves the randomized controlled trial of recombinant human growth hormone combined alginate dressing in the treatment of DFU in 7 electronic databases, such as PubMed, EMbase, Cochrane Library, SinoMed, CNKI, WANGFANG database, and VIP database. All the retrieval dates of database are from the establishment of the database until May 31, 2020. At the same time, searching the related degree papers, conference papers, and other gray literature by manual. The original literature data are independently screened and extracted by 2 researchers on the basis of inclusion and exclusion criteria and literature information sheets, and cross-checked and resolved through group discussions and consultations when there are differences of the opinion. Assessing the methodological quality of inclusion in the study based on the "Bias Risk Assessment Form" of the Cochrane Collaboration Network. Using the software of RevMan 5.3.3 and STATA 13.0 for statistical analysis.
Results:
This study compares the main and secondary outcome indicators by systematic evaluation and it will provide strong evidence of recombinant human growth hormone combined alginate dressing in the treatment of DFU.
Ethics and dissemination:
All data in this study are obtained through the web database and do not involve humans, so ethical approval is not suitable for this study.
Osf registration number:
DOI 10.17605/OSF.IO/W6P24.
Conclusion:
This study will give positive conclusions about the effectiveness and safety of recombinant human growth hormone combined alginate dressing in the treatment of DFU.
... (3) La PND es uno de los factores responsables del pie diabético, determinante de discapacidad, de ulceraciones y amputaciones, responsable de alteraciones de la marcha y lesiones relacionadas con caídas. (4,5) Es por tanto una situación clínica que incide directamente sobre la calidad y expectativa de vida de estos pacientes. ...
The main chronic complication of diabetes mellitus is neuropathy, in particular diabetic polyneuropathy. The objective of this study was to evaluate the prevalence of polyneuropathy and its association with risk factors and chronic complications in a diabetes unit. In a population of 81 diabetic patients, a polyneuropathy prevalence of 34.6% was found. It is more frequent and severe in the T2DM population, and was associated with longer disease progression and microangiopathic complications. Symptomatic polyneuropathy predominated in the female sex. It is concluded that the diabetic population should undergo timely screening for polyneuropathy.
... El Cloruro de cobalto que tiene el dispositivo cambia de color azul a rosa en un tiempo máximo de 10 min. Si cambia de color la prueba se considera como negativa para NPD [10][11][12][13][14] . Esta prueba ya ha sido aceptada como una de las pruebas de valoración de neuropatía diabética por el Panel de Consenso de toronto 15 . ...
Background:
Sudomotor dysfunction may appear in early stages of diabetic neuropathy.
Aim:
To evaluate the diagnostic capacity of the Neuropad test, based on the detection of sudomotor dysfunction, as an early indicator of diabetic neuropathy.
Material and Methods:
In Forty-two type 2 diabetic patients, the Neuropad test was compared with the 10 g monofilament test (proposed in the technical orientation of diabetic foot of the Ministry of Health of Chile), deep and thermal sensitivity.
Results:
The surface sensitivity assessed with a brush had a sensitivity and specificity of 18.8 and 100% respectively when compared with the 10 g monofilament. When compared with the Neuropad, the figures were 9 and 100%, respectively. Pain perception sensitivity and specificity were 13 and 100% respectively when compared with the 10 g monofilament. The figures were 6 and 100%, when compared with the Neuropad. Thermal discrimination had a sensitivity and specificity of 88 and 33% respectively when compared with the 10 g monofilament. The figures were 75 and 25% respectively when compared with the Neuropad. The deep sensitivity evaluated with a 128 Hz tuning fork had a sensitivity and specificity of 31 and 100% respectively when compared with the 10 g monofilament. The figures were 16 and 31% respectively when compared with the Neuropad. The Neuropad had a sensitivity and specificity of 94 and 29% respectively were compared with the 10 g monofilament.
Conclusions:
Neuropad had a good diagnostic yield for the early detection of sudomotor dysfunction.
... According to the National Institute for Health and Care Excellence (NICE), false positives are preferable to false negatives leading to the recommendation of 10-g monofilament, despite the lack of evidence supporting its use [16]. Some authors motivate the use of complementary diagnostic or screening tests together with the monofilament testing [14], such as Neuropad, which is a simple sudomotor function test (SFT) [17]. Neuropad is the only self-testing device for sudomotor function available for use in a primary care or the home setting. ...
Objective
To carry out a cost-effectiveness analysis of the use of Neuropad as a screening test for diabetic neuropathy together with the standard care tool, the 10-g monofilament, in people with diabetes.
Research design and methods
A cost-effectiveness analysis using a Markov model was developed to assess the impact on costs and outcomes of using Neuropad as a test for diabetic neuropathy (1) as a complement to the standard test, the 10-g monofilament (Neuropad + monofilament vs. monofilament); and (2) as a substitute for the monofilament (Neuropad vs. monofilament); from the healthcare provider perspective. The time horizon was 3 years. Data on costs and health gains were extracted from the literature. The incremental cost–utility ratio was calculated. Deterministic and probabilistic sensitivity analyses were also performed.
Results
Compared with standard care, Neuropad, in combination with the 10-g monofilament tool, is the dominant strategy as it leads to higher health gains and lower costs. In practice, compared with using the monofilament alone, performing both tests would lead to a savings of £1049.26 per patient and 0.044 QALY gain. Results were found to be consistent across the sensitivity analyses.
Conclusions
Using both screening tools (Neuropad + monofilament) is a cost-effective strategy and the dominant alternative, when compared against using the 10-g monofilament alone. The results would be of special relevance in the early detection of diabetic peripheral neuropathy and to ensure the efficient allocation of resources and, thus, the sustainability of healthcare systems.
... Current research in Spain related to diabetic foot is a focus on early detection of diabetic neuropathies, which can prevent the diabetic foot ulcers apparition [68]. Perception among 83% of general practitioners in Spain showed that management of diabetic foot ulcers is thought to be organized by multidisciplinary teams, with a presence of specialized podiatrists [69]. ...
One of the diseases that could affect diabetic patients is the diabetic foot problem. Unnoticed minor injuries and subsequent infection can lead to ischemic ulceration, and may end in a foot amputation. Preliminary studies have shown that there is a positive relationship between increased skin temperature and the pre–ulceration phase. Hence, we have carried out a review on wearables, medical devices, and sensors used specifically for collecting vital data. In particular, we are interested in the measure of the foot–temperature. Since there is a large amount of this type of medical wearables, we will focus on those used to measure temperature and developed in Spain.
The aim. To study the prevalence of various combinations of polymorphic variants of genes markers of endothelial function and vascular-platelet hemostasis in the development of diabetic foot syndrome. Materials and methods. In 198 patients with uncomplicated diabetes mellitus and 199 patients with diabetic foot syndrome, the frequency of polymorphic variants of the NOS 786C>T, END1 Lys198Asn, ITGB3 1565T>C (Leu33Pro), F5 1691G>A, F2 20210G>A, MMP9 8202A>G, MTHFR 1298A>C, VEGFA-634C>G genes was studied. Using binary logistic regression analysis, the relationship of various combinations of polymorphisms of the studied genes with the development of diabetic foot was assessed. Results. In diabetic foot syndrome, the most significant contribution is made by the combination of polymorphic variants of the ITGB3 1565T>C (Leu33Pro) and MTHFR 1298A>C genes. With the development of this complication of diabetes mellitus, a combination of the 1565 TC polymorphism of gene ITGB3 and the 1298AA polymorphism of gene MTHFR is 2.1 times more common. The association of the 1565TT polymorphism of gene ITGB3 and the 1298AC polymorphism of gene MTHFR is 2 times more common in diabetes mellitus without complications. Conclusion. The combination of the 1565TС polymorphism of gene ITGB3 and the 1298АА polymorphism of gene MTHFR is associated with the risk of developing a diabetic foot and increases the risk of developing this complication by 2.4 times. The presence of a combination of the 1565TT polymorphisms of gene ITGB3 and the 1298AC polymorphism of gene MTHFR is more common in uncomplicated diabetes mellitus, which suggests its protective effect against the development of diabetic foot syndrome.
Patients with diabetes mellitus may experience painful and nonpainful diabetic peripheral neuropathy (DPN). This article offers an overview of DPN and the clinical assessment and management of patients with DPN, as well as the nurse's role in supporting these patients.
Background and objective:
Type 2 diabetes mellitus (T2DM) complications seriously affect the quality of life and could not be cured completely. Actions should be taken for prevention and self-management. Analysis of warning factors is beneficial for patients, on which some previous studies focused. They generally used the professional medical test factors or complete factors to predict and prevent, but it was inconvenient and impractical for patients to self-manage. With this in mind, this study built a Bayesian network (BN) model, from the perspective of diabetic patients' self-management and prevention, to predict six complications of T2DM using the selected warning factors which patients could have access from medical examination. Furthermore, the model was analyzed to explore the relationships between physiological variables and T2DM complications, as well as the complications themselves. The model aims to help patients with T2DM self-manage and prevent themselves from complications.
Methods:
The dataset was collected from a well-known data center called the National Health Clinical Center between 1st January 2009 and 31st December 2009. After preprocess and impute the data, a BN model merging expert knowledge was built with Bootstrap and Tabu search algorithm. Markov Blanket (MB) was used to select the warning factors and predict T2DM complications. Moreover, a Bayesian network without prior information (BN-wopi) model learned using 10-fold cross-validation both in structure and in parameters was added to compare with other classifiers learned using 10-fold cross-validation fairly. The warning factors were selected according the structure learned in each fold and were used to predict. Finally, the performance of two BN models using warning features were compared with Naïve Bayes model, Random Forest model, and C5.0 Decision Tree model, which used all features to predict. Besides, the validation parameters of the proposed model were also compared with those in existing studies using some other variables in clinical data or biomedical data to predict T2DM complications.
Results:
Experimental results indicated that the BN models using warning factors performed statistically better than their counterparts using all other variables in predicting T2DM complications. In addition, the proposed BN model were effective and significant in predicting diabetic nephropathy (DN) (AUC: 0.831), diabetic foot (DF) (AUC: 0.905), diabetic macrovascular complications (DMV) (AUC: 0.753) and diabetic ketoacidosis (DK) (AUC: 0.877) with the selected warning factors compared with other experiments.
Conclusions:
The warning factors of DN, DF, DMV, and DK selected by MB in this research might be able to help predict certain T2DM complications effectively, and the proposed BN model might be used as a general tool for prevention, monitoring, and self-management.
Foot problems complicating diabetes are a source of major patient suffering and societal costs. Investing in evidence-based, internationally appropriate diabetic foot care guidance is likely among the most cost-effective forms of healthcare expenditure, provided it is goal-focused and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has been publishing and updating international Practical Guidelines since 1999. The 2015 updates are based on systematic reviews of the literature, and recommendations are formulated using the Grading of Recommendations Assessment Development and Evaluation (GRADE) system. As such, we changed the name from "Practical Guidelines" to "Guidance". In this article we describe the development of the 2015 IWGDF Guidance documents on prevention and management of foot problems in diabetes. This Guidance consists of five documents, prepared by five working groups of international experts. These documents provide guidance related to foot complications in persons with diabetes on: prevention; footwear and offloading; peripheral artery disease; infections; and, wound healing interventions. Based on these five documents, the IWGDF Editorial Board produced a summary guidance for daily practice. The resultant of this process, after review by the Editorial Board and by international IWGDF members of all documents, is an evidence-based global consensus on prevention and management of foot problems in diabetes. Plans are already under way to implement this Guidance. We believe that following the recommendations of the 2015 IWGDF Guidance will almost certainly result in improved management of foot problems in persons with diabetes and a subsequent worldwide reduction in the tragedies caused by these foot problems. This article is protected by copyright. All rights reserved.
Foot deformities, neuropathy, and dysfunction in the lower extremities are known risk factors that increase plantar peak pressure (PP) and, as a result, the risk of developing foot ulcers in patients with diabetes. However, knowledge about the prevalence of these factors is still limited. The aim of the present study was to describe the prevalence of risk factors observed in patients with diabetes without foot ulcers and to explore possible connections between the risk factors and high plantar pressure.
Patients diagnosed with type 1 (n=27) or type 2 (n=47) diabetes (mean age 60.0±15.0 years) were included in this cross-sectional study. Assessments included the registration of foot deformities; test of gross function at the hip, knee, and ankle joints; a stratification of the risk of developing foot ulcers according to the Swedish National Diabetes Register; a walking test; and self-reported questionnaires including the SF-36 health survey. In-shoe PP was measured in seven regions of interests on the sole of the foot using F-Scan(®). An exploratory analysis of the association of risk factors with PP was performed.
Neuropathy was present in 28 (38%), and 39 (53%) had callosities in the heel region. Low forefoot arch was present in 57 (77%). Gait-related parameters, such as the ability to walk on the forefoot or heel, were normal in all patients. Eighty percent had normal function at the hip and ankle joints. Gait velocity was 1.2±0.2 m/s. All patients were stratified to risk group 3. Hallux valgus and hallux rigidus were associated with an increase in the PP in the medial forefoot. A higher body mass index (BMI) was found to increase the PP at metatarsal heads 4 and 5. Pes planus was associated with a decrease in PP at metatarsal head 1. Neuropathy did not have a high association with PP.
This study identified several potential risk factors for the onset of diabetic foot ulcers (DFU). Hallux valgus and hallux rigidus appeared to increase the PP under the medial forefoot and a high BMI appeared to increase the PP under the lateral forefoot. There is a need to construct a simple, valid, and reliable assessment routine to detect potential risk factors for the onset of DFU.
Neuropad is a simple visual indicator test, with moderate diagnostic performance for diabetic peripheral neuropathy. As it assesses sweating, which is a measure of cholinergic small nerve fibre function, we compared its diagnostic performance against established measures of both large and, more specifically, small fibre damage in patients with diabetes.
One hundred and twenty-seven participants (89 without diabetic peripheral neuropathy and 38 with) aged 57 ± 9.7 years underwent assessment with Neuropad, large nerve fibre assessments: (Neuropathy Disability Score, vibration perception threshold, peroneal motor nerve conduction velocity); small nerve fibre assessments: neuropathy symptoms using the Diabetic Neuropathy Symptoms score (corneal nerve fibre length and warm perception threshold).
Neuropad has a high sensitivity but moderate specificity against large fibre neuropathy assessments: Neuropathy Disability Score (> 2) 70% and 50%, vibration perception threshold (> 14 V) 83% and 53%, and peroneal motor nerve conduction velocity (< 42 m/s) 81% and 54%, respectively. However, the diagnostic accuracy of Neuropad was significantly improved against corneal nerve fibre length (< 14 mm/mm2) with a sensitivity and specificity of 83% and 80%, respectively. Furthermore, the area under the curve for corneal nerve fibre length (85%) was significantly greater than with the Neuropathy Disability Score (66%, P = 0.01) and peroneal motor nerve conduction velocity (70%, P = 0.03). For neuropathic symptoms, sensitivity was 78% and specificity was 60%.
The data show the improved diagnostic performance of Neuropad against corneal nerve fibre length. This study underlines the importance of Neuropad as a practical diagnostic test for small fibre neuropathy in patients with diabetes.
The implementation of an inpatient diabetic foot service should be the goal of all institutions that care for patients with diabetes. The objectives of this team are to prevent problems in patients while hospitalized, provide curative measures for patients admitted with diabetic foot disorders, and optimize the transition from inpatient to outpatient care. Essential skills that are required for an inpatient team include the ability to stage a foot wound, assess for peripheral vascular disease, neuropathy, wound infection, and the need for debridement; appropriately culture a wound and select antibiotic therapy; provide, directly or indirectly, for optimal metabolic control; and implement effective discharge planning to prevent a recurrence. Diabetic foot ulcers may be present in patients who are admitted for nonfoot problems, and these ulcers should be evaluated by the diabetic foot team during the hospitalization. Pathways should be in place for urgent or emergent treatment of diabetic foot infections and neuropathic fractures/dislocations. Surgeons involved with these patients should have knowledge and interest in limb preservation techniques. Prevention of iatrogenic foot complications, such as pressure sores of the heel, should be a priority in patients with diabetes who are admitted for any reason: all hospitalized diabetic patients require a clinical foot exam on admission to identify risk factors such as loss of sensation or ischemia. Appropriate posthospitalization monitoring to reduce the risk of reulceration and infection should be available, which should include optimal glycemic control and correction of any fluid and electrolyte disturbances.
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.
Vibration perception threshold (VPT) is considered as a gold standard for diagnosis of diabetic peripheral neuropathy. However, the data are sparse comparing the VPT with commonly used bedside modalities. This study was carried out to evaluate the usefulness of simple bed side screening modalities for peripheral neuropathy in patients with diabetes mellitus.
A total of 1044 patients with diabetes mellitus attending the Diabetes clinic from January 2007 to May 2008, were included in this study. All subjects had a detailed clinical assessment including Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, ankle reflex, vibration sensation with a 128 Hz tuning fork, 10 g Semmes-Weinstein monofilament and vibration perception threshold (VPT).
The prevalence of peripheral neuropathy was 34.9 per cent with VPT. Foot care practices were followed by only 214 (20.5%) of the study population. When compared with VPT, ankle reflex was the most sensitive (90.7%) but least specific (37.3%). The tuning fork and monofilament tests respectively had lower sensitivity (62.5 and 62.8%) but better specificity (95.3 and 92.9%) and accuracy (78.9 and 77.9%). Significant correlations were observed between the VPT score and the DNE (r = 0.532, P<0.001) and DNS (r = 0.546, P<0.001) scores and absent tuning fork sensation (r = 0.590; P<0.001), monofilament sensation (r = 0.573; P<0.001) and ankle reflex (r = 0.377, P = 0.01).
The present findings show that simple bed side tests are useful for assessing peripheral diabetic neuropathy, even in those subjects in whom foot care practices are not followed.
To estimate the accuracy of Neuropad for the diagnosis and staging of distal symmetric polyneuropathy (DPN) across different stages of neuropathy, using multiple-level likelihood ratios (LRs) to interpret the time necessary to complete the color change of the test.
We conducted a cross-sectional, cohort-type diagnostic accuracy study in 251 consecutive adult type 2 diabetic patients with no peripheral arterial disease or other potential causes of neuropathy, who were recruited between January 2005 and December 2008 from the diabetes outpatient clinics in Alexandroupolis Hospital, Greece. Patients were tested for DPN by means of the neuropathy disability score (NDS) and Neuropad. Multiple-level LRs for time to complete color change were calculated across different stages of neuropathy.
The areas under the curve for the diagnosis of any (NDS of ≥3), at least moderate (NDS of ≥6), or severe (NDS of ≥9) DPN were 0.91, 0.96, and 0.97, respectively. The calculation of multiple-level LRs showed that time to complete color change <360 s suggested the absence of neuropathy. Values between 360 and 1,000 s were indicative of mild neuropathy. Finally, values between 1,000 and 1,200 or >1,200 s were strongly suggestive of moderate or severe DPN, respectively.
Neuropad could be used as a triage test for the diagnosis and staging of DPN in patients with type 2 diabetes, prompting referral to specialized care setting.
Several risk stratification systems have been proposed for predicting development of diabetic foot ulcer. However, little has been published that assesses their similarities and disparities, diagnostic accuracy and evidence level. Consequently, we conducted a systematic review of the existing stratification systems.
We searched the MEDLINE database for studies (published until April 2010) describing the creation and validation of risk stratification systems for prediction of diabetic foot ulcer development.
We included 13 studies describing or evaluating the following different risk degree stratification systems: University of Texas; International Working Group on Diabetic Foot; Scottish Intercollegiate Guideline Network (SIGN); American Diabetes Association; and Boyko and colleagues. We confirmed that five variables were included in almost all the systems: diabetic neuropathy, peripheral vascular disease, foot deformity, and previous foot ulcer and amputation. The number of variables included ranged from four to eight and the number of risk groups from two to six. Only four studies reported or allowed the calculation of diagnostic accuracy measures. The SIGN system showed some higher diagnostic accuracy values, particularly positive likelihood ratio, while predictive ability was confirmed through external validation only in the system of Boyko et al.
Foot ulcer risk stratification systems are a much needed tool for screening patients with diabetes. The core variables of various systems are very similar, but the number of included variables in each model and risk groups varied greatly. Overall, the quality of evidence for these systems is low, as little validation of their predictive ability has been done.
Preceding the joint meeting of the 19th annual Diabetic Neuropathy Study Group of the European Association for the Study of Diabetes (NEURODIAB) and the 8th International Symposium on Diabetic Neuropathy in Toronto, Canada, 13-18 October 2009, expert panels were convened to provide updates on classification, definitions, diagnostic criteria, and treat merits of diabetic peripheral neuropathies (DPNs), autonomic neuropathy, painful DPNs, and structural alterations in DPNs. Diabetes Care 33:2285-2293, 2010
In 2006 a risk stratification model was developed by Boyko et al. to predict foot ulceration in patients with diabetes, using seven commonly available clinical variables. We sought to validate and optimise this clinical prediction rule in a different setting.
A retrospective cohort study was conducted on all patients with diabetes attending the podiatry section of a diabetic foot clinic at a tertiary hospital in Portugal (n = 360). Assessment at baseline included variables evaluated in the previous study and other relevant variables.
Type 2 diabetes was present in 98% of patients, 45% were men and (at baseline) the median age was 65 years. Median follow-up was 25 months (range 3-86), during which 94 patients (26%) developed a foot ulcer. Boyko's model had an area under the receiver operating curve of 0.83 (95% CI 0.78-0.88). The corresponding value for the optimised model, which included the footwear risk variable, was 0.88 (95% CI 0.84-0.91). Both models had high classification accuracy for prediction of foot ulceration. However, the optimised model tended to produce higher specificity and positive likelihood ratio values at all levels.
This study confirmed that Boyko's proposed model has a high capacity to predict foot ulceration in diabetes patients of both sexes. Our results suggest that the inclusion of a further footwear variable could improve the model. Nevertheless, prospective validation in a larger population is still necessary.
The aim of this study was to examine the reproducibility of the new indicator test for sudomotor function (Neuropad) in type 2 diabetic patients. The study included 142 type 2 diabetic patients (70 men) with a mean age of 67.3 +/- 7.6 years and a mean diabetes duration of 14.2 +/- 6.3 years. Sudomotor function was assessed by means of colour change in the indicator test. Each patient was examined twice. Moreover, inter-observer variability was assessed in 60 patients (35 patients with sudomotor dysfunction, 25 patients without sudomotor dysfunction). In the right foot, a highly significant (r = 0.91, p = 0.001) correlation was observed between time until complete colour change of the test on the first (910.7 +/- 431.6 seconds) and second examination (935.8 +/- 440.1 seconds). In the left foot, a highly significant (r = 0.89, p = 0.001) correlation was observed between time until complete colour change of the test on the first (911.6 +/- 430.3 seconds) and second examination (940.5 +/- 441.2 seconds). Reproducibility was excellent both in patients with sudomotor dysfunction (p = 0.001) and in those without sudomotor dysfunction (p = 0.001). Agreement in diagnosis of sudomotor dysfunction between the two examinations was 98 %. Inter-observer reproducibility was excellent (p = 0.001), both in patients with sudomotor dysfunction and in those without sudomotor dysfunction. Intra- and interobserver Coefficient of Variance ranged between 4.1 % and 5.1 %. CONCLUSIONS: These results indicate that reproducibility of the new indicator test for sudomotor function is excellent in type 2 diabetic patients with or without sudomotor impairment.
The ability of readily available clinical information to predict the occurrence of diabetic foot ulcer has not been extensively studied. We conducted a prospective study of the individual and combined effects of commonly available clinical information in the prediction of diabetic foot ulcer occurrence.
We followed 1,285 diabetic veterans without foot ulcer for this outcome with annual clinical evaluations and quarterly mailed questionnaires to identify foot problems. At baseline we assessed age; race; weight; current smoking; diabetes duration and treatment; HbA(1c) (A1C); visual acuity; history of laser photocoagulation treatment, foot ulcer, and amputation; foot shape; claudication; foot insensitivity to the 10-g monofilament; foot callus; pedal edema; hallux limitus; tinea pedis; and onychomycosis. Cox proportional hazards modeling was used with backwards stepwise elimination to develop a prediction model for the first foot ulcer occurrence after the baseline examination.
At baseline, subjects were 62.4 years of age on average and 98% male. Mean follow-up duration was 3.38 years, during which time 216 foot ulcers occurred, for an incidence of 5.0/100 person-years. Significant predictors (P </= 0.05) of foot ulcer in the final model (hazard ratio, 95% CI) included A1C (1.10, 1.06-1.15), impaired vision (1.48, 1.00-2.18), prior foot ulcer (2.18, 1.61-2.95), prior amputation (2.57, 1.60-4.12), monofilament insensitivity (2.03, 1.50-2.76), tinea pedis (0.73, 0.54-0.98), and onychomycosis (1.58, 1.16-2.16). Area under the receiver operating characteristic curve was 0.81 at 1 year and 0.76 at 5 years.
Readily available clinical information has substantial predictive power for the development of diabetic foot ulcer and may help in accurately targeting persons at high risk of this outcome for preventive interventions.
Peripheral neuropathy remains a major cause of morbidity and is a cardinal factor in the pathogenesis of diabetic foot ulceration. The aim of the present study was to compare the new indicator test for sudomotor function (Neuropad®) with the vibration perception threshold (VPT) and the clinical examination in the diagnosis of peripheral neuropathy in subjects with type 2 diabetes. This study included 154 type 2 diabetic patients (76 men) with a mean age of 64.3±7.3 years and a mean diabetes duration of 12.8±4.3 years. Neuropathy was diagnosed clinically using the Neuropathy Disability Score (NDS). The VPT was measured with a neurothesiometer, values25Volts being classified as abnormal. Sudomotor function was evaluated by the indicator test. Sensitivity of the indicator test for neuropathy was 97.8% and specificity was 67.2%. Sensitivity and specificity of VPT for neuropathy were 78.9% and 85.9% respectively. A significant correlation was shown between time to colour change of the indicator test and VPT (rs=0.889, p<0.001).
Conclusions: Both the indicator test and the VPT have a high sensitivity for neuropathy. Sensitivity is higher with the indicator test, but specificity is higher with VPT. Time until complete colour change of the indicator test shows a positive correlation with VPT. Thus, the indicator test appears to be a useful additional diagnostic tool of neuropathy, particularly suitable for screening and self-examination, in type 2 diabetes. The correlation between time to colour change of the indicator test and VPT is interesting and merits investigation in a prospective study.
The commercially available Neuropad test was developed as a simple visual indicator test to evaluate diabetic neuropathy. It uses a colour change to define the integrity of skin sympathetic cholinergic innervation. We compared the results of Neuropad assessment in the foot with established measures of somatic and autonomic neuropathy.
Fifty-seven diabetic patients underwent Neuropad assessment, quantitative sensory and autonomic function testing, and evaluation of intra-epidermal nerve fibre density in foot skin biopsies.
Neuropad responses correlated with the neuropathy disability score (r(s)=0.450, p<0.001), neuropathic symptom score (r(s)=0.288, p=0.03), cold detection threshold (r(s)=0.394, p = 0.003), heat-as-pain perception threshold visual analogue score 0.5 (r(s)=0.279, p=0.043) and deep-breathing heart rate variability (r(s)= -0.525, p<0.001). Intra-epidermal nerve fibre density (fibres/mm) compared with age- and sex-matched control subjects (11.06+/-0.82) was non-significantly reduced (7.37+/-0.93) in diabetic patients with a normal Neuropad response and significantly reduced in patients with a patchy (5.01+/-0.93) or absent (5.02+/-0.77) response (p=0.02). The sensitivity of an abnormal Neuropad response in detecting clinical neuropathy (neuropathy disability score >or=5) was 85% (negative predictive value 71%) and the specificity was 45% (positive predictive value 69%).
The Neuropad test may be a simple indicator for screening patients with diabetic neuropathy.
The future for diabetes is grave. Now described as the global epidemic of the 21st century, the increasing incidence of diabetes (in 2007 over 246 million people affected by diabetes) will place considerable strain on resources and will bring suffering to many if the preventative measures promoted by the International Diabetes Federation (IDF), the International Working Group on the Diabetic Foot (IWGDF) and other diabetes representative organizations are not put into effect.
Ulcers of the foot in diabetes are a source of major suffering and cost. Investing in a diabetic foot care guideline can be one of the most cost-effective forms of healthcare expenditure, provided the guideline is goal-focused and properly implemented. The objective of the IWGDF, founded in 1996, is to develop guidelines that will reduce the impact of diabetic foot disease through cost-effective and quality healthcare, based on the principles of evidence-based medicine. Three IWGDF working groups were invited to write specific consensus guidelines on different subjects, according to the current standards of evidence based medicine. Therefore, for the first time, new 2007 texts were produced according to a systematic review of the literature, in order to inform protocols for routine care and to highlight areas which should be considered for further study. After reaching worldwide consensus, the review reports and specific guidelines were launched in May 2007. Copyright
In 2015, it can be said that the diabetic foot is no longer the Cinderella of diabetic complications. Thirty years ago there was little evidence-based research taking place on the diabetic foot, and there were no international meetings addressing this topic. Since then, the biennial Malvern Diabetic Foot meetings started in 1986, the American Diabetes Association founded their Foot Council in 1987, and the European Association for the Study of Diabetes established a Foot Study Group in 1998. The first International Symposium on the Diabetic Foot in the Netherlands was convened in 1991, and this was soon followed by the establishment of the International Working Group on the Diabetic Foot that has produced useful guidelines in several areas of investigation and the management of diabetic foot problems. There has been an exponential rise in publications on diabetic foot problems in high impact factor journals, and a comprehensive evidence-base now exists for many areas of treatment. Despite the extensive evidence available, it, unfortunately, remains difficult to demonstrate that most types of education are efficient in reducing the incidence of foot ulcers. However, there is evidence that education as part of a multi-disciplinary approach to diabetic foot ulceration plays a pivotal role in incidence reduction. With respect to treatment, strong evidence exists that offloading is the best modality for healing plantar neuropathic foot ulcers, and there is also evidence from 2 randomized controlled trials to support the use of negative-pressure wound therapy in complex post-surgical diabetic foot wounds. Hyperbaric oxygen therapy exhibits the same evidence level and strength of recommendation. International guidelines exist on the management of infection in the diabetic foot. Many randomized trials have been performed, and these have shown that the agents studied generally produced comparable results, with the exception of one study in which tigecycline was shown to be clinically inferior to ertapenem±vancomycin. Similarly, there are numerous types of wound dressings that might be used in treatment and which have shown efficacy, but no single type (or brand) has shown superiority over others. Peripheral arterial disease is another major contributory factor in the development of ulceration, and its presence is a strong predictor of non-healing and amputation. Despite the proliferation of endovascular procedures in addition to open revascularization, many patients continue to suffer from severely impaired perfusion and exhaust all treatment options. Finally, the question of the true aetiopathogenesis of Charcot neuroarthropathy remains enigmatic, although much work is currently being undertaken in this area. In this area, it is most important to remember that a clinically uninfected, warm, insensate foot in a diabetic patient should be considered as a Charcot foot until proven otherwise, and, as such, treated with offloading, preferably in a cast. This article is protected by copyright. All rights reserved.
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)
The aim is to compare the frequency of increased vibration perception threshold (VPT) with abnormal 10‐g Semmes‐Weinstein monofilament (SWF) testing in a non‐selected diabetic population, and to assess the agreement between these two screening methods. VPT was measured using a neurothesiometer at the pulp of the hallux and 10‐g SWF was applied on three plantar sites on each foot according to the guidelines of the International Working Group on the Diabetic Foot, in 400 consecutive diabetic patients. VPT was considered as abnormal if ≥25 V and SWF was considered as abnormal if the patient was unable to feel ≥2 applications at a single site.
Both tests were normal in 240 patients (60%) and both abnormal in 78. In 21 patients, only SWF was abnormal whereas only VPT was abnormal in 61. As a whole, 160 patients (40%) were considered at risk for foot ulceration by VPT and/or SWF. Agreement between the two screening methods was only moderate with a kappa coefficient of 0·52 (95% CI: 0·43–0·60). Using VPT as a predictor for foot ulceration, the number of patients at risk is much higher than identified by SWF. This discrepancy might have potential effects on costs and prevention policies.
The International Working Group on the Diabetic Foot (IWDGF) has produced in 2011 a guideline on the diagnosis and treatment of peripheral arterial disease in patients with diabetes and a foot ulcer. This document, together with a systematic review that provided the background information on management, was produced by a multidisciplinary working group of experts in the field and was endorsed by the IWDGF. This progress report is based on these two documents and earlier consensus texts of the IWDGF on the diagnosis and management of diabetic foot ulcers. Its aim is to give the clinician clear guidance on when and how to diagnose peripheral arterial disease in patients with diabetes and a foot ulcer and when and which treatment modalities should be considered, taking both risks and benefits into account.
Small fibres constitute 70–90% of peripheral nerve fibres and regulate several key functions such as tissue blood flow, temperature and pain perception as well as sweating, all of which are highly relevant to the clinical presentation and adverse outcomes associated with foot ulcerations in patients with diabetes. Recent studies demonstrated significant abnormalities in the small fibres in subjects with impaired glucose tolerance and diabetes, despite normal electrophysiology, suggesting that the earliest nerve fibre damage is to the small fibres. Unfortunately, guidelines and consensus statements focus on large fibres and continue to advocate electrophysiology as a diagnostic modality and as a primary end point for the assessment of therapeutic benefit. (In part, this reflects the difficulties in quantifying small fibre dysfunction and damage.) We have therefore critically assessed currently available techniques that measure small fibre dysfunction in diabetic neuropathy, using quantitative sensory and sudomotor testing. We have assessed the role of identifying structural damage by quantifying intraepidermal nerve fibre density in skin biopsies and corneal nerve morphology using corneal confocal microscopy. Finally, we propose a definition for diabetic neuropathy that incorporates small fibre damage. Copyright © 2011 John Wiley & Sons, Ltd.
To examine the sensitivity and specificity of three cut-off points of Neuropad for the diagnosis of distal symmetric polyneuropathy and small-fibre dysfunction in patients within the first year after diagnosis of diabetes.
Neuropad results were read at 10, 15 and 20 min and evaluated for diagnostic utility in distal symmetric polyneuropathy confirmed by electrophysiology and small-fibre dysfunction in 52 patients with Type 1 diabetes and 99 patients with Type 2 diabetes.
The prevalence of distal symmetric polyneuropathy was 15.4% in Type 1 diabetes and 43.4% in Type 2 diabetes, while that of small-fibre dysfunction was 9.6 and 31.3%, respectively. Sensitivity of Neuropad for the diagnosis of distal symmetric polyneuropathy and small-fibre dysfunction was highest in Type 1 diabetes for the 10-min threshold reaching 87.5 and 80.0%, respectively, while it was modestly high in Type 2 diabetes at 65.1 and 67.7%, respectively. Specificity in both diabetes types was modest for the 10-min threshold (44.7-48.2%). It was highest for the 20-min threshold (83.8-89.3%) at the cost of poor sensitivity at 12.5-34.9%. Negative predictive values were relatively high for all three cut-off points in both types of diabetes (64.1-97.1%) at the cost of poor positive predictive values at 12.5-71.4%.
In patients within the first year after diagnosis of diabetes, the 10-min cut-off for Neuropad provides a relatively high sensitivity and modest specificity for distal symmetric polyneuropathy and small-fibre dysfunction, rendering the test more suitable as a screening tool than the 15- and 20-min cut-offs.
Diabetic peripheral neuropathy is a major complication of diabetes mellitus (DM) and is the leading cause of foot ulceration and lower extremity amputations (LEAs). The purpose of this systematic review is to evaluate current evidence regarding the prognostic value of the Semmes Weinstein monofilament examination (SWME) in predicting foot ulceration and LEA in patients with DM.
The MEDLINE/PubMed database was searched through November 2009 for articles pertaining to diabetic foot and SWME with no language or publication date restrictions. Prognostic studies with original data assessing the predictive value of SWME for foot ulceration or LEA in patients with DM were included in the selection. Data were systematically extracted and analyzed by two independent investigators. Absolute risks and relative risks were determined for each study.
Of the 863 studies identified, nine articles were relevant, involving 11,007 patients with DM. Six studies were identified that assessed the prognostic value of SWME regarding diabetic foot ulceration. The relative risk for patients with a positive SWME result versus those with a negative result ranged from 2.5 (95% confidence interval [CI], 2.0 to 3.2) to 7.9 (95% CI, 4.4 to 14.3) in the identified studies with follow up between 1 and 4 years. Three of the studies assessed the risk of LEA with a positive SWME result. The relative risk for LEA ranged from 1.7 (95% CI, 1.1 to 2.6) to 15.1 (95% CI, 4.3 to 52.6) with follow-up between 1.5 and 3.3 years.
All nine studies found SWME to be a significant and independent predictor of future foot ulceration or likely of future LEA as well in patients with DM. Therefore, SWME is an important evidence-based tool for predicting the prognosis of patients with diabetic foot, thus enabling improved patient selection for early intervention and management. More research should be conducted to elucidate the relationship between SWME and LEA.
Aim: The aim of this prospective study was to evaluate the contribution of the indicator test for sudomotor function Neuropad® to the early diagnosis of peripheral neuropathy in patients with type 2 diabetes mellitus. Included were 109 type 2 diabetic patients (55 men, mean age 56.15±6.14 years), whose initial clinical examination (Neuropathy Disability Score, NDS) was negative for neuropathy. Patients were first examined between January and June 2004 and re-examined 5 years later by the NDS and Neuropad®. Initially, 70 patients (64.22%) had normal and 39 (35.78%) patients had abnormal Neuropad® (groups A and B, respectively). NDS was significantly higher in group B on both examinations (p<0.001). On the second examination, 2 patients (2.86%) in group A and 10 patients (25.64%) in group B had developed neuropathy (p=0.001). Neuropad® had 83.33% sensitivity and 68.04% specificity for neuropathy. There was a modest but significant agreement (kappa=0.259, p<0.001) between Neuropad® and NDS for neuropathy.
Conclusions: Among type 2 diabetic patients with normal NDS, development of neuropathy is significantly more frequent in those with abnormal Neuropad®. These results suggest a potential utility of Neuropad® for the earlier diagnosis of neuropathy in type 2 diabetes.
Diabetes mellitus is one of the most prevalent chronic diseases worldwide including Singapore. The 10g monofilament is commonly used by clinicians to examine diabetic patients for neuropathy due to its low cost and convenience. The aim of this literature review is to evaluate the use of the monofilament and the factors that affect its diagnostic value.
A systematic search of AMED, Medline, EMBASE and Cinahl databases was conducted to identify English language articles from 1990 to 2009 which investigated the use of the monofilament.
A total of 34 studies were identified, consisting of 24 observational studies, 8 prospective studies, 1 review article and 1 randomised controlled trial. 6 recurrent themes emerged from these 34 studies.
The 10g monofilament remains a useful clinical tool for detecting severe neuropathy and hence identifying patients at increased risk of ulceration and amputation. However, a consensus on the protocol in the use of the monofilament needs to be reached. Further research regarding the effects of environmental conditions on the accuracy of the monofilament is also essential.
We wanted to summarize evidence about the diagnostic accuracy of the 5.07/10-g monofilament test in peripheral neuropathy.
We conducted a systematic review of studies in which the accuracy of the 5.07/10-g monofilament was evaluated to detect peripheral neuropathy of any cause using nerve conduction as reference standard. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool.
We reviewed 173 titles and abstracts of articles to identify 54 potentially eligible studies, of which 3 were finally selected for data synthesis. All studies were limited to patients with diabetes mellitus and showed limitations according to the QUADAS tool. Sensitivity ranged from 41% to 93% and specificity ranged from 68% to 100%. Because of the heterogenous nature of the studies, a meta-analysis could not be accomplished.
Despite the frequent use of monofilament testing, little can be said about the test accuracy for detecting neuropathy in feet without visible ulcers. Optimal test application and defining a threshold should have priority in evaluating monofilament testing, as this test is advocated in many clinical guidelines. Accordingly, we do not recommend the sole use of monofilament testing to diagnose peripheral neuropathy.
The purpose of this systematic review is to evaluate current evidence in the literature on the efficacy of Semmes Weinstein monofilament examination (SWME) in diagnosing diabetic peripheral neuropathy (DPN).
The PubMed database was searched through August 2008 for articles pertaining to DPN and SWME with no language or publication date restrictions. Studies with original data comparing the diagnostic value of SWME with that of one or more other modalities for DPN in patients with diabetes mellitus were analyzed. Data were extracted by two independent investigators. Diagnostic values were calculated after classifying data by reference test, SWME methodology, and diagnostic threshold.
Of the 764 studies identified, 30 articles were selected, involving 8365 patients. There was great variation in both the reference test and the methodology of SWME. However, current literature suggests that nerve conduction study (NCS) is the gold standard for diagnosing DPN. Four studies were identified which directly compared SWME with NCS and encompassed 1065 patients with, and 52 patients without diabetes mellitus. SWME had a sensitivity ranging from 57% (95% confidence interval [CI], 44% to 68%) to 93% (95% CI, 77% to 99%), specificity ranging from 75% (95% CI, 64% to 84%) to 100% (95% CI, 63% to 100%), positive predictive value (PPV) ranging from 84% (95% CI, 74% to 90%) to 100% (95% CI, 87% to 100%), and negative predictive value (NPV) ranging from 36% (95% CI, 29% to 43%) to 94% (95% CI, 91% to 96%).
There is great variation in the current literature regarding the diagnostic value of SWME as a result of different methodologies. To maximize the diagnostic value of SWME, a three site test involving the plantar aspects of the great toe, the third metatarsal, and the fifth metatarsals should be used. Screening is vital in identifying DPN early, enabling earlier intervention and management to reduce the risk of ulceration and lower extremity amputation.
This independent study was designed to determine the accuracy of 10-g monofilaments manufactured and supplied by popular commercial companies.
A total of 160 new 10-g monofilaments (30 Semmes-Weinstein monofilaments [North Coast Medical], 30 Timesco/Sensory Testing Systems monofilaments, 50 Owen Mumford Neuropens, and 50 Bailey Instruments monofilaments) were tested using a calibrated load cell. Each monofilament was subjected to 10 mechanical bucklings of 10 mm while the load cell detected the maximum buckling force. Longevity testing was performed on a subset of the monofilaments by subjecting them to continuous compressions until the buckling force was <9 g.
The accuracy of monofilaments to produce a buckling force of 10 g varies among manufacturers. Bailey Instruments and Owen Mumford filaments were the most accurate with 100% buckling within +/-1.0 g of 10 g. Only 70% of the Semmes-Weinstein monofilaments from North Coast Medical buckled within +/-1.0 g of 10 g. A total of 80% of Timesco filaments buckled at <8 g. Longevity tests on Bailey Instruments and Owen Mumford monofilaments demonstrated that 80% continued to buckle within 10% of 10 g after 100 compressions, but only 50% were within this range after 200 compressions. The maximum amount of recovery achieved in any monofilament occurred within 24 h.
Monofilaments made by either Bailey Instruments or Owen Mumford are recommended for use in clinical practice. North Coast Medical monofilaments may operate differently in the U.S. because of different environmental conditions such as differences in humidity. Timesco/Sensory Testing Systems monofilaments were neither accurate enough nor Conformity European marked to recommend their use in the U.K. Longevity and recovery testing suggest that each monofilament will survive usage on approximately 10 patients before needing a recovery time of 24 h before further use.
To evaluate the effectiveness of a diabetic foot risk classification system by the International Working Group on the Diabetic Foot to predict clinical outcomes.
A total of 225 diabetic patients were initially evaluated as part of a prospective case-control study at the University of Texas Health Science Center at San Antonio. Complete records were available for 213 patients for follow-up evaluation after 29 months. Upon enrollment, subjects were stratified into four risk groups based on the presence of risk factors according to the consensus of the International Working Group on the Diabetic Foot. Group 0 consisted of subjects without neuropathy, group 1 consisted of patients with neuropathy but without deformity or peripheral vascular disease (PVD), group 2 consisted of subjects with neuropathy and deformity or PVD, and group 3 consisted of patients with a history of foot ulceration or a lower-extremity amputation.
Upon enrollment, patients in higher-risk groups had longer duration of diabetes, worse glycemic control, vascular and neuropathic variables, and more systemic complications of diabetes. During 3 years of follow-up, ulceration occurred in 5.1, 14.3, 18.8, and 55.8% of the patients in groups 0, 1, 2, and 3, respectively (linear-by-linear association, P < 0.001). All amputations were found in Groups 2 and 3 (3.1 and 20.9%, P < 0.001).
The foot risk classification of the International Working Group on the Diabetic Foot predicts ulceration and amputation and can function as a tool to prevent lower-extremity complications of diabetes.
This trial assessed whether a simple clinical tool can be used to stratify patients with diabetes, according to risk of developing foot ulceration. This was a prospective, observational follow-up study of 3526 patients with diabetes (91% type 2 diabetes) attending for routine diabetes care. Mean age was 64.7 (range 15-101) years and duration of diabetes was 8.8 (+/-1.5 SD) years. Patients were categorised into 'low' (64%), 'moderate' (23%) or 'high' (13%) risk of developing foot ulcers by trained staff using five clinical criteria during routine patient care. During follow-up (1.7 years), 166 (4.7%) patients developed an ulcer. Foot ulceration was 83 times more common in high risk and six times more in moderate risk, compared with low-risk patients. The negative predictive value of a 'low-risk score' was 99.6% (99.5-99.7%; 95% confidence interval). This clinical tool accurately predicted foot ulceration in routine practice and could be used direct scarce podiatry resources towards those at greatest need.
This review assesses the progress that has been made over the last quarter century in our understanding of the pathogenesis of diabetic foot problems as well as in their management. Some recent exciting developments are highlighted. This is followed by a brief discussion on the epidemiology and causal pathways to diabetic foot disease.
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