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Determinants and estimation of healing times in diabetic foot ulcers
Abstract
To assess the wound size reduction and time course for healing and to establish equations to predict the time course of wound healing in neuropathic, neuroischemic, and ischemic diabetic foot ulcers.
This prospective study evaluates wound healing over at least a 10-week period in 31 Type 1 or Type 2 diabetic patients with plantar foot ulcers. Thirteen consecutive diabetic patients with neuropathic foot ulceration, 10 consecutive diabetic patients with neuroischemic ulceration, and 8 diabetic patients with peripheral occlusive vascular disease were selected for the study. All patients received identical ulcer wound care including use of proper footwear, non-weight-bearing limb support, use of appropriate antibiotics, debridement, tight control of serum glucose levels, and careful monitoring of the ulcer. Ulcer healing was assessed by planimetric measurement of the wound area every second week until wound healing. The time course of wound healing was calculated by the daily wound radius reduction.
The wound area (mean+/-S.E.) in the patients with neuropathic foot ulceration was 61.2+/-17.1 at the beginning and 3.2+/-1.5 mm(2) after 70 days (P=.005). The wound radius decreased by 0.045 mm (95% confidence interval [CI] 0.039-0.055) per day, with most of the wound healing being achieved between the first and seventh week of ulcer care. The average healing time was 77.7 (95% CI 62-93) days. In the neuroischemic group, the initial average wound area was 26.6+/-7.0 mm(2), and 6.25+/-1.7 mm(2) after 10 weeks (P=.007). The wound radius reduction was 0.019 mm/day (95% CI 0.017-0.023) with an average healing time of 123.4 (95% CI 101-145) days. The diabetic patients with peripheral occlusive vascular disease had an average wound size of 32.6+/-13.1 at the beginning and 23.9+/-10.7 mm(2) after 70 days of ulcer care (P=.06). The daily wound radius reduction was 0.0065 mm (95% CI 0.0039-0.0091). Average ulcer duration was 133 (95% CI 116-149) days, but three of eight patients achieved no wound healing.
Providing standard care, the time course of wound healing in diabetic foot ulcers is predominantly determined by etiologic factors, and less by wound size. Taking wound etiology and wound radius into account, the expected healing time can reliably be estimated in neuropathic and neuroischemic ulcers.
... Diabetes is one of the most common metabolic disorders known as a delay in wound healing. About 15% of diabetic patients develop foot ulcers [4], and these patients are vulnerable to chronic wounds such as diabetic foot and leg ulcers. These ulcers have less potential for regeneration. ...
... These ulcers have less potential for regeneration. In other words, failure to heal these wounds can lead to the amputation of the patients [4][5][6]. Moncada and Higgs reported that diabetes reduces nitric oxide in wound sites [7]. ...
... The water uptake ratio is urgent for removing excess exudates from wounds and retaining the wound site's moist environment. Figure 4(a) shows the water uptake ratio of CMC-ALg and CMC-ALg-GSNO in various periods of time (1,4,8,12,18,24, and 48 h). For CMC-ALg, water uptake was 4501.6% ± 154.1%. ...
Today, despite significant progress in developing skin tissue engineering products, the fabrication of an ideal wound dressing that could meet the essential criteria, such as promoting angiogenesis -mainly in a diabetic wound- still remains a challenge. A diabetic wound is a chronic wound in which vascularization is low, and the wound healing process may stop. In this regard, Nitric oxide (NO) enhances the healing of diabetic wounds by promoting angiogenesis and providing antibacterial activity in wound sites. In this study, we produced a NO-releasing wound dressing (CMC-ALg-GSNO) composed of Carboxymethyl chitosan (CMC), sodium alginate (ALg), and Snitrosoglutathione (GSNO). The results obtained from the scanning electron microscopy (SEM) show that wound dressing has a porous structure. The water uptake and water vapor transmission for the wound dressing were obtained 4354.1 ± 179.3 % and 2753.8 ± 54.6 g/m2 per day, respectively. NO release study showed that NO release from CMC-ALg-GSNO continuously occurred within 168 hours. In vivo test, The CMC-ALg-GSNO wound dressing developed wound healing in a rat model of full-thickness diabetic wounds compared to the CMC-ALg and Gauze wound dressings. Thus, this study showed that CMC-ALg-GSNO wound dressing could lead to novel therapeutic invasions to treat diabetic wounds.
... The latter stages of complications are usually associated with serious morbidity and reduction of quality of life. By history and through clinical examination, diabetic foot ulcers fall into three categories: neuropathic, neuroischemic, and ischemic [6,12,21,22]. Their management has been addressed in various ways, and this has led to the recommendation and implementation of various local or regional clin-ical practical guidelines [6]. Nevertheless, all these clinical practical guidelines tend to follow the same patterns that include foot evaluation, pharmacological therapy, offloading, wound dressing, negative pressure wound therapy, and education for patients and relatives [2,6,19]. ...
... As all patients were admitted into the same department, on same wards, and were treated by the same medical staff, this hospital LOS could only be subjective to the quality of therapy. One of the key issues for the therapy of DFU is the prolonged wound healing time, which may have resulted from traditional treatment [21]. The etiological and anatomical heterogeneity of diabetic foot ulcers have made challenging the assessment of wound healing and prediction of healing time [11]. ...
... Data have shown that one-third of neuropathic ulcer completely healed after 20 weeks of good care [44], and the wound size reduction within the first month of treatment can be a prognostic factor of healing rate [45]. A validated equation established by Zimny et al. [21] found to be reliable is used as a prognostic assessment tool of healing time in diabetic neuropathic foot ulcers. In the current study, both groups recorded a significant decrease of wound area after 12 weeks. ...
This study explored the clinical effectiveness of antibiotic-loaded bone cement on primary treatment of diabetic foot infection. This is a randomized controlled study, including thirty-six patients with diabetic foot ulcer complicated by osteomyelitis who had undergone treatment between May 2018 and December 2019. Patients were randomly divided into control group (group A) and study group (group B). Patients in the intervention group received antibiotic-loaded bone cement repair as primary treatment, while patients in the control group received conventional vacuum sealing draining treatment. Clinical endpoints were assessed and compared between the two groups, including wound healing time, wound bacterial conversion, NRS pain score, number of wound dressing changes, and average hospitalization time. All patients were followed up for a period of 12 months after discharge. Results show that compared with the control group, patients in the study group had significant difference in the number of patients for baseline pathogens eradication, short NRS pain score, hospital length of stay and cost, wound surface reduction, healing time, low rate of complications, and infection recurrence. Based on the findings, we conclude that antibiotic-loaded bone cement can be used for treatment of wound in patient with diabetic foot infection. It can help to control wound infections, shorten hospital length of stay, reduce medical cost, and relieve both doctors' and patients' burden. The application of antibiotic-loaded bone cement is suitable for diabetic wound with soft tissue infection or osteomyelitis.
... After this assessment and review of references 19 studies were included in the final review ( Figure 1). [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] The date of publication ranged from 1985 to 2014, 2 studies were randomized controlled trials (RCTs), there were 3 pseudo-RCTs and the rest were observational studies ( Table 2). Not all studies included all the comparisons considered below and some studies used more than 1 method to assess the microcirculation. ...
... There is disagreement on how to carry out each of the methods of assessing the microcirculation, including positioning of the probes and in the case of TcPO 2 the skin temperature that recordings were made at. Probes were most commonly positioned on the dorsum of the foot, 11,12,15,17,20,26,27 but they are also positioned peri-wound 12,18,21,24 and in 1 case it was not stated. 14 A possible explanation for Yotsu et al not detecting a significant difference is their method of measurement. ...
... 2 was most commonly measured at 44°C 12,15,18,20,21,24 but also at 45°C 11,14 or not stated. 17,[26][27][28] Due to the variety of countries and inclusion/exclusion criteria, the cohorts differed across the studies. For example, Yang et al 26 15,26 This threshold, when looking at the collated results in the healed and unhealed groups in Table 3, appear to hold true when considering the healed groups, all the mean results are above 25 mmHg. ...
Background:
Diabetic foot disease carries a high morbidity and is a leading cause of lower limb amputation. This may in part be due to the effect diabetes mellitus (DM) has on the microcirculation including in the skin.
Method:
We conducted a review of studies that have examined the relationship between microcirculatory function and wound healing in patients with DM. A search of the Medline, Embase, and Web of Science databases was performed coupled with a review of references for the period 1946 to March 2015.
Results:
Nineteen studies of diverse methodology and cohort selection were identified. Poor function of the microcirculation was related to poor outcome. Transcutaneous oxygen pressure (TcPO2) was the most commonly used method to measure the microcirculation and thresholds for poor outcome proposed ranged from 10 mmHg to <34 mmHg. Two studies reexamined microcirculatory function following revascularization. Both found an increase in TcPO2, however only 1 reached statistical significance. No significant difference in the results of microcirculation tests was found between diabetic and nondiabetic patients.
Conclusions:
While it is not possible to draw firm conclusions from the evidence currently available there are clear areas that warrant research. Good microcirculation unsurprisingly appears to associate with better wound healing. The influence of DM is not clear, and neither is the degree of improvement required to achieve healing. Studies that examine a clearly defined cohort both with and without DM are urgently required. Accurate quantitative assessment of microcirculation will aid prediction of wound healing identifying those at greatest risk of amputation.
... In recent years, several papers confirmed the therapeutic efficacy of various forms of ozone therapy in the treatment of DFUs [16,[25][26][27][28]. ...
... Zimny et al. also assessed the course and effectiveness of treatment of foot ulcers of neuropathic, neuro-ischemic, and ischemic etiology in 31 patients with type 1 or type 2 diabetes for over 10 weeks. The analysis of the obtained results showed that, if proper care is provided, the wound healing time in diabetic foot ulcers depends mainly on the etiological factors causing the development of the ulcer and, to a lesser extent, on its surface area [28]. ...
Background: Diabetes ranks high among worldwide global health problems, and diabetic foot ulcer syndrome (DFU) is considered as one of its most serious complications. The purpose of this study was to evaluate the impact of local ozone therapy procedures on the wound healing process in patients with two DFU types: neuropathic and ischemic. Material and Methods: In the retrospective study reported here, the treatment outcomes of 90 patients were analyzed: 44 males (48.8%) and 46 females (51.2%), in the age range between 38 and 87 years of age, with neuropathic (group 1) and ischemic (group 2) diabetic foot ulcers treated by means of local ozone therapy. The assessment of therapeutic effects in both groups of patients included an analysis of the rate of ulcer healing using planimetry and an analysis of the intensity of pain associated with ulcers performed using the VAS scale. Results: After the application of ozone therapy procedures, a statistically significant decrease in the surface area of the ulcers was obtained in both groups of patients, respectively: in group 1 from 7 (6–7.5) cm2 to 3 (2–3.5) cm2 and in group 2 from 7.5 (6.5–8) cm2 to 5 (4.5–5.5) cm2 (p < 0.001), with a complete healing of ulcers not observed in any patients from groups 1 and 2. After treatment, the surface area of the assessed ulcers was smaller in the neuropathic group. The intensity of pain experienced after treatment also decreased with statistical significance in both groups (p < 0.001). Conclusions: Short-term local ozone therapy was effective in promoting wound healing and alleviating pain in patients with DFUs of both neuropathic and ischemic etiology. The effectiveness of therapy in the neuropathic type of DFUs was significantly higher than in the ischemic type, in which patients had a higher incidence of risk factors and more advanced lesions, characterized by a larger initial ulcer area and greater intensity of pain.
... Therefore, we per- Between 19% and 34% of diabetes patients are affected DFU during their lifetime, and the rate of recurrence of DFU is more than 50% after 3 years. 8) According to a retrospective study by Monami et al., 9) 53.8% of 196 DFU patients did not heal within 6 months, and a conservative approach was found to be more economical and convenient than major amputation as treatment. Diabetic foot problems impose a major economic burden, and costs increase proportionately to the severity of the condition. ...
... Milne et al.2) reported 83 days (mean 122 days) for DFU with soft tissue infection only.In addition, they reported that 8% of unhealed. Zimny et al.8) reported that the wound radius decreased by 0.045 mm (95% confidence interval [CI], 0.039∼0.055 mm) per day and the average healing time was 77.7 days (95% CI, 62∼93 days) in neuropathic DFU with no ischemic or peripheral occlusive vascular diseases. ...
Wound healing is impaired in diabetes, because the biochemical and immunological pathologies up to cellular level affect the entire process of wound recovery. 1) In diabetic foot, wound healing is 2 to 3 times slower than non-diabetes. 2) Chronic nonhealing foot ulcers occur in approximately 15% of patients with diabetes. 1) Because chronicity in diabetic foot ulcer (DFU) significantly increases healthcare costs and the possibility of infection and lower leg amputation, early regeneration treatment with infection control and blood flow improvement are important for the prognosis. Tissue regen-eration therapies using living cells and biosynthetic materials have become available recently. However, most of these are still expensive or not readily applicable for many reasons. 1) Because the regeneration and immune modulation effects of platelet-rich plasma (PRP) on DFU have been sufficiently proven, the author planned intralesional autologous PRP injection for a chronicized recalcitrant Wagner grade 2 DFU. 3-5) The author experienced a case of autologous platelet-rich plasma (PRP) affecting the recovery of a chronic neuropathic diabetic foot ulcer combined with infection. A 65-year-aged male with uncontrolled diabetes presented with a Wagner grade 2 diabetic foot ulcer on his left forefoot of more than 2 weeks duration. Osteomyelitis, gangrene, and ischemia requiring acute intervention were absent. Although infection was controlled to a moderate degree, wound healing was unsatisfactory following surgical debridement and simple dressing. Therefore, intralesional autologous PRP injection was performed 5 times as an adjuvant regeneration therapy, and the recalcitrant ulcer healed in 3 months. Intralesional PRP injections are worthwhile as they promote wound regeneration, are evidence-based, safe, and can be easily performed in ambulatory care facilities.
... Responders were patients who healed within 111 days. (37,38) Hypertension was significantly (p = 0.0001) responsible for delayed healing. We noted no significant difference in other clinical features (age, sex, diabetes, smoking, body mass index (BMI), heart rate, blood pressure, and oxygen saturation) between the two groups. ...
... 111-days was used as a cutoff for this classification based on previously reported values in literature. (37,38) The green shaded region (n = 9 wounds) in Figure 4A shows wounds classified as responders to therapy. The other 11 wounds were classified as non-responders. ...
Chronic wounds are a major health problem that cause the medical infrastructure billions of dollars every year. Chronic wounds are often difficult to heal and cause significant discomfort. Although wound specialists have numerous therapeutic modalities at their disposal, tools that could 3D-map wound bed physiology and guide therapy do not exist. Visual cues are the current standard but are limited to surface assessment; clinicians rely on experience to predict response to therapy. Photoacoustic (PA) ultrasound (US) is a non-invasive, hybrid imaging modality that can solve these major limitations. PA relies on the contrast generated by hemoglobin in blood which allows it to map local angiogenesis, tissue perfusion and oxygen saturation - all critical parameters for wound healing. This work evaluates the use of PA-US to monitor angiogenesis and stratify patients responding vs. not-responding to therapy. We imaged 19 patients with 22 wounds once a week for at least three weeks. Our findings suggest that PA imaging directly visualizes angiogenesis. Patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase (p = 0.002). These responders had a significant and negative correlation between PA intensity and wound size. Hypertension was correlated to impaired angiogenesis in non-responsive patients. The rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring (power = 88%, alpha = 0.05) This early response detection system could help inform management and treatment strategies while improving outcomes and reducing costs.
... Diabetic foot ulcers (DFUs) are serious complications in diabetic patients. Lack of effective intervention directed towards healing of the ulcers can lead to foot or lower limb amputation and even morbidity in extreme cases [1]. These not only have negative impact on the quality of lives of the patients, but also impose a huge economic burden on the healthcare systems. ...
... Diabetes is a multi-organ systemic disease; hence there can be many additional disorders or diseases co-occurring with it. These co-morbid diseases play important role in the healing of these ulcers [1]. Some of the important diseases which have been reported to affect the healing are peripheral vascular disease (PVD), cardiovascular diseases such as ischemic heart disease (IHD) * and kidney disorders such as chronic kidney disease (CKD) [4][5][6]. ...
The area of the diabetic foot ulcer (DFU) and its reduction over weeks is used for assessment in clinical practices; however, literature reports that this is not reliable parameter. This work has investigated the association of change in the mean temperature of the ulcers with three clinical conditions relevant to wound healing, i.e. peripheral vascular disease (PVD), chronic kidney disease (CKD) and ischemic heart disease (IHD). Thermal and RGB images of 23 DFUs of the first two weeks of ulceration were studied. One-way ANOVA was performed on the change in mean temperature of the ulcers and change in area and it was found that the weekly change in mean temperature was higher for patients with CKD (p-value=0.009). Also, change in area measured from RGB images did not show any association with the clinical conditions. The application of this work is that the temperature obtained from thermal image of the ulcer can be used as a prognostic parameter for its assessment.
... Several studies have investigated factors related to the healing time of DFU (diabetic foot ulcer). Evidence suggests a possible association between healing time and factors such as HbA 1c , ulcer size, infection, peripheral artery disease, etiology, and longer duration of diabetes [4][5][6][7]. A recent study presented a linear relationship between HbA 1c and the healing rate of diabetic foot ulcers (every 1% increase in baseline HbA 1c resulted in a decrease of wound area healed per day by 0.028 cm 2 , p = 0 02) [4]. ...
... We found a median duration of ulcer of 6 months in 1999 and 6.6 months in 2012, which is a relatively long time compared to five other DFU studies, which showed mean or median healing times of 1-4 months [5][6][7][8]11]. ...
Aim:
To describe differences in healing time of diabetic foot ulcers for patients treated at the Copenhagen Wound Healing Center, Bispebjerg Hospital, between the years 1999/2000 and 2011/2012. The Center is highly specialized and receives diabetes patients with hard-to-heal foot ulcers. A further aim is to attempt to find predictors of healing time of diabetic foot ulcers.
Methods:
A retrospective descriptive study of records from patients with diabetic foot ulcer treated at the Copenhagen Wound Healing Center in 1999, 2000, 2011, or 2012. Follow-up data was collected until the 3rd of August 2018.
Results:
Median time (range) to healing was 6 (61.3) months in 1999/2000 and 6.6 (67.8) in 2011/2012 (p = 0.2). About 33% of ulcers were healed, 17% were minor or major amputated, and 1.5% were dead within one year in 1999/2000, whereas 30% of ulcers were healed (p = 0.6), 14% were amputated (p = 0.2), and 12.8% were dead within one year in 2011/2012 (p < 0.001). The single factor found significantly associated with longer ulcer duration was infection. Related to shorter ulcer duration were toe localization of the ulcer and good glycemic control.
Conclusion:
The median time to healing of a diabetic foot ulcer was long, around 6 months and with a high recurrence rate in 1999/2000 as well as in 2011/2012. Some factors were found to be significantly related to healing time, and intervention addressing these may improve the time to heal, although such interpretations must be taken with precaution from the present study and should be proven in randomized prospective intervention trials.
... 8 Another study 9 on venous leg ulcers reported a median time to healing in three treatment arms of 84, 77, and 91 days. Studies in diabetic foot 10 and pressure ulcers 11 have reported a median healing time of 10 weeks. ...
... Four studies considered more than one definition. 10,45,53,59 Overall, almost half of the studies (20/42) were prospective, but only three investigated pressure ulcer healing. 38,53,56 The most common statistical method used to analyse the data was regression analysis (30/42), and this was Cox regression in nine cases. ...
Healing of non‐traumatic skin ulcers is often suboptimal. Prognostic tools that identify people at high risk of delayed healing within the context of routine ulcer assessments may improve this, but robust evidence on which factors to include is lacking. Therefore, we scoped the literature to identify which potentially prognostic factors may warrant future systematic reviews and meta‐analyses. We conducted electronic searches in MEDLINE and Embase to identify studies in English published between 1997 and 2017 that tested the association between healing of the three most common non‐traumatic skin ulcers encountered by health care professionals (venous leg, diabetic foot, and pressure ulcers) and patient characteristics, ulcer characteristics, and results from clinical investigations. We included 42 studies that investigated factors which may be associated with the healing of venous leg ulcers (n = 17), diabetic foot ulcers (n = 15), and pressure ulcers (n = 10). Across ulcer types, ulcer characteristics were most commonly reported as potential prognostic factors for healing (n = 37), including the size of the ulcer area (n = 29) and ulcer duration at first assessment (n = 16). A total of 35 studies investigated the prognostic value of patient characteristics (n = 35), including age (n = 31), gender (n = 30), diabetes (n = 22), smoking status (n = 15), and history of deep vein thrombosis (DVT) (n = 13). Of these studies, 23 reported results from clinical investigations as potential prognostic factors, with the majority regarding vessel quality. Age, gender, diabetes, smoking status, history of DVT, ulcer area, and ulcer duration at time of first assessment warrant a systematic review and meta‐analysis to quantify their prognostic value for delayed ulcer healing.
... The average wound size was 23 ± 18 cm 2 (range 6-63 cm 2 ) and the time to complete wound healing 23 ± 10 weeks (9-41 weeks) on average. To achieve this, a total of 133 Omega3 wound matrices (size 3 × 7 cm) were used (median 17 [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] patches/patient). ...
... A comparison of the wound healing kinetics of patients at the Mainz center with curves from a study on ischemic and nonischemic wounds also confirmed that the wounds in the Mainz group of patients were adequately perfused/revascularized [18]. By implication, this underscores the need to investigate arterial tissue perfusion and implement appropriate revascularizing measures in the case of local ischemia prior to resection/minor amputation. ...
Introduction
The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing. The aim of this study was to report the cumulative experience of three centers for vascular surgery regarding use of the Omega3 Wound matrix in selected patients with complicated wounds.
Material and methods
In this study 23 patients with 25 vascular and/or diabetes mellitus-associated complicated wounds and partially exposed bony segments were treated with the Omega3 Wound matrix in three vascular centers. In several patients, conventional wound treatment with vacuum therapy had previously been carried out sometimes over several weeks without durable success. Following initial debridement in the operating room, the matrix was applied and covered with a silicone mesh. In the further course, wound treatment was conducted on an outpatient setting if possible.
Results
In total 25 wounds were treated with localization at the level of the thigh (n = 2), the distal calf (n = 7), the forefoot (n = 14) and the hand (n = 2). The time to heal varied between 9 and 41 weeks and between 3 and 26 wound matrices were applied per wound. Interestingly, a reduction of analgesics intake was noted when the treatment with the Omega3 Wound matrix was initiated.
Conclusion
The novel Omega3 Wound matrix in this study represented an effective treatment option in 25 complicated wounds. Further studies are necessary to evaluate the impact of the wound matrix on stimulation of granulation tissue and re-epithelialization as well as the potential antinociceptive and analgetic effects.
... Diabetic foot ulcer (DFU) is the most common complication of T2DM (2,3). Approximately, 25% of all T2DM patients will develop a DFU in their lifetime, with over 65% of DFUs reoccurring within 5 years post-healing (4,5). It is estimated that 50% of DFUs will become infected, resulting in a 155-fold increased risk of amputation compared to sterile DFUs (6,7). ...
Diabetic foot ulcers (DFUs) are the most common complications of diabetes resulting from hyperglycemia leading to ischemic hypoxic tissue and nerve damage. Staphylococcus aureus is the most frequently isolated bacteria from DFUs and causes severe necrotic infections leading to amputations with a poor 5-year survival rate. However, very little is known about the mechanisms by which S. aureus dominantly colonizes and causes severe disease in DFUs. Herein, we utilized a pressure wound model in diabetic TALLYHO/JngJ mice to reproduce ischemic hypoxic tissue damage seen in DFUs and demonstrated that anaerobic fermentative growth of S. aureus significantly increased the virulence and the severity of disease by activating two-component regulatory systems leading to expression of virulence factors. Our in vitro studies showed that supplementation of nitrate as a terminal electron acceptor promotes anaerobic respiration and suppresses the expression of S. aureus virulence factors through inactivation of two-component regulatory systems, suggesting potential therapeutic benefits by promoting anaerobic nitrate respiration. Our in vivo studies revealed that dietary supplementation of L-arginine (L-Arg) significantly attenuated the severity of disease caused by S. aureus in the pressure wound model by providing nitrate. Collectively, these findings highlight the importance of anaerobic fermentative growth in S. aureus pathogenesis and the potential of dietary L-Arg supplementation as a therapeutic to prevent severe S. aureus infection in DFUs.
IMPORTANCE
S. aureus is the most common cause of infection in DFUs, often resulting in lower-extremity amputation with a distressingly poor 5-year survival rate. Treatment for S. aureus infections has largely remained unchanged for decades and involves tissue debridement with antibiotic therapy. With high levels of conservative treatment failure, recurrence of ulcers, and antibiotic resistance, a new approach is necessary to prevent lower-extremity amputations. Nutritional aspects of DFU treatment have largely been overlooked as there has been contradictory clinical trial evidence, but very few in vitro and in vivo modelings of nutritional treatment studies have been performed. Here we demonstrate that dietary supplementation of L-Arg in a diabetic mouse model significantly reduced duration and severity of disease caused by S. aureus . These findings suggest that L-Arg supplementation could be useful as a potential preventive measure against severe S. aureus infections in DFUs.
... Poor healing of venous ulcers may be a sign of a more severe underlying venous illness, but it is also possible that fibroblasts have aged and are less responsive to proliferative stimuli as a result of extended exposure to the environment of chronic venous ulcers (47)(48)(49). The average healing time for diabetic foot ulcers was 77.7 days (50), while the average healing time for venous ulcers varied: there was a 17% chance of the ulcer healing in 40 days, a 47% chance in 80 days, and a 77% chance in 120 days (51). ...
Introduction
Chronic venous and diabetic ulcers are hard to treat that cause patients long time of suffering as well as significant healthcare and financial costs.
Purpose
The conducted study was to evaluate the efficacy of bee venom (BV) phonophoresis on the healing of chronic unhealed venous and/or diabetic foot ulcers Also, to compare the healing rate of diabetic and venous ulcers.
Methodology
The study included 100 patients (71 males and 29 females) with an age range of 40-60 years' old who had chronic unhealed venous leg ulcers of grade I, grade II, or diabetic foot ulcers with type II diabetes mellitus. They randomly assigned into four equal groups of 25: Group A (diabetic foot ulcer study group) and group C (venous ulcer study group) who both received conservative treatment of medical ulcer care and phonophoresis with BV gel, in addition to group B (diabetic foot ulcer control group) and group D (venous ulcer control group) who both received conservative treatment of medical ulcer care and received ultrasound sessions only without BV gel. Wound surface area (WSA) and ulcer volume measurement (UVM) were used to assess the ulcer healing pre-application (P 0 ), post-6 weeks of treatment (P 1 ), and after 12 weeks of treatment (P 2 ). In addition to Ki-67 immunohistochemistry was used to evaluate the cell proliferative in the granulation tissue of ulcers pre-application (P 0 ) and after 12 weeks of treatment (P 2 ) for all groups.
Results
This research revealed a statistical significance improvement (p ≤ 0.0) in the WSA, and UVM with no significant difference between study groups after treatment. Regarding Ki-67 immunohistochemistry showed higher post treatment values in the venous ulcer group in comparison to the diabetic foot ulcer group.
Conclusion
Bee venom (BV) provided by phonophoresis is effective adjuvant treatment in accelerating venous and diabetic foot ulcer healing with higher proliferative effect on venous ulcer.
Clinical trial registration
www.ClinicalTrials.gov , identifier: NCT05285930.
... Since the population with DM is heterogeneous, in this study different groups of persons with DM and LOPS are distinguished, based on severity of the disease (HoU versus no-HoU) and experience with TF. It is expected that persons who have experienced the impact of an ulcer (long healing time and necessity of good wound care) [16,17]) will have different motivations for using TF compared with persons without ulcers. Other influencing factors are duration of TF use, positive or negative experiences with TF use, and type of footwear used. ...
Background
Persons with diabetes mellitus (DM) and loss of protective sensation (LOPS) due to peripheral neuropathy do not use their therapeutic footwear (TF) consistently. TF is essential to prevent foot ulceration. In order to improve compliance in using TF, influencing factors need to be identified and analyzed. Persons with a history of foot ulceration may find different factors important compared with persons without ulceration or persons who have never used TF. Therefore, the objective of this study was to determine factors perceived as important for the use of TF by different groups of persons with DM and LOPS.
Method
A qualitative study was performed using focus group discussions. Subjects (n = 24) were divided into 3 focus groups based on disease severity: ulcer history (HoU) versus no ulcer history (no-HoU) and experience with TF (TF) versus no experience (no-TF). For each group of 8 subjects (TF&HoU; TF&no-HoU; no-TF&no-HoU), an online focus group discussion was organized to identify the most important influencing factors. Transcribed data were coded with Atlas.ti. The analysis was performed following the framework approach.
Results
The factors comfort and fit and stability/balance were ranked in the top 3 of all groups. Usability was ranked in the top 3 of group-TF&noHoU and group-noTF&noHoU. Two other factors, reducing pain and preventing ulceration were ranked in the top 3 of group-TF&noHoU and group-TF&HoU, respectively.
Conclusion
Experience with TF and a HoU influence which factors are perceived as important for TF use. Knowledge of these factors during the development and prescription process of TF may lead to increased compliance. Although the main medical reason for TF prescription is ulcer prevention, only 1 group gave this factor a high ranking. Therefore, next to focusing on influencing factors, person-centered education on the importance of using TF to prevent ulcers is also required.
... Diabetes-related foot ulceration (DFU) is a common limbthreatening complication estimated to impact up to 34% of people with diabetes in their lifetime, 1 with approximately 50% of ulcers developing an infection, 2,3 and 20% resulting in amputation. [3][4][5] DFU pose a significant burden to both individuals and the healthcare system, with prolonged healing times, significant rates of morbidity and mortality, [6][7][8] and negative impacts on quality of life. 9 It is estimated that diabetes-related foot disease has an annual global cost of approximately 1.6 billion US dollars, 10,11 and is the leading cause of global diabetes-related hospitalisation, amputation and disability burdens. ...
Objective:
Diabetes related foot ulceration (DFU) is a common limb threatening condition, which is complex and subsequently challenging to manage. The aim of this study was to determine the contribution of a range of clinical and social factors to healing of diabetes-related foot ulceration in an Australian population.
Research design and methods:
This was a prospective cohort study of individuals with diabetes-related foot ulceration (DFU). Age, sex, medical history, medications, dietary supplementation (e.g. vitamin C intake) and smoking history were elicited at baseline. Index of relative socioeconomic disadvantage (IRSD) was calculated. The Australian Eating Survey and International Physical Activity Questionnaire-short were administered. Wound history, size, grade, time to healing and infection were captured and monitored over six months. Logistic regression was performed to determine the relationship between healing, and diet quality, toe systolic pressure, wound size, IRSD, infection and previous amputation.
Results:
117 participants were included. The majority were male n= 96(82%), socioeconomically disadvantaged (mean IRSD 965, SD 60), and obese (BMI 36kg/m2, SD 11) with a long history of diabetes (20 years, SD 11). Wounds were predominantly neuropathic (n=85, 73%) and classified 1A (n=63, 54%) on the University of Texas wound classification system with few infections (n=23, 16%). Dietary supplementation was associated with 4.36 increased odds of healing (95%1.28-14.84, p=0.02), greater levels of socioeconomic advantage was also associated with increased odds of healing (OR 1.01, 95%CI 1.01-1.02, p=0.03).
Conclusions:
In this cohort study of predominantly neuropathic, non-infected DFU, individuals who had greater levels of socioeconomic advantage had significantly greater odds of DFU healing. Diet quality was poor in most participants, with individuals taking supplementation significantly more likely to heal.
... This evaluation time point was determined based on published clinical trials on diabetic wound healing. 27,28 Safety was evaluated based on the incidence of adverse events (AEs), and the severity of AEs was evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 3). ...
Non-healing wounds are among the main causes of morbidity and mortality. We recently described a novel, serum-free ex vivo expansion system, the quantity and quality culture system (QQc), which uses peripheral blood mononuclear cells (PBMNCs) for effective and noninvasive regeneration of tissue and vasculature in murine and porcine models. In this prospective clinical study, we investigated the safety and efficacy of QQ-cultured peripheral blood mononuclear cell (MNC-QQ) therapy for chronic non-healing ischemic extremity wounds. Peripheral blood was collected from 9 patients with 10 chronic (>1 month) non-healing wounds (8 males, 1 female; 64-74 years) corresponding to ischemic extremity ulcers. PBMNCs were isolated and cultured using QQc. Within a 20-cm area surrounding the ulcer, 2 × 107 cells were injected under local anesthesia. Wound healing was monitored photometrically every 2 weeks. The primary endpoint was safety, whereas the secondary endpoint was efficacy at 12-week post-injection. All patients remained ambulant, and no deaths, other serious adverse events, or major amputations were observed for 12 weeks after cell transplantation. Six of the 10 cases showed complete wound closure with an average wound closure rate of 73.2% ± 40.1% at 12 weeks. MNC-QQ therapy increased vascular perfusion, skin perfusion pressure, and decreased pain intensity in all patients. These results indicate the feasibility and safety of MNC-QQ therapy in patients with chronic non-healing ischemic extremity wounds. As the therapy involves transplanting highly vasculogenic cells obtained from a small blood sample, it may be an effective and highly vasculogenic strategy for limb salvage.
... In all cases, in the postsurgical period, after suturing the wound, programmable sanitation was used. Patients of the studied groups received complex therapy, which included complete foot unloading, insulin therapy with fractional administration of adequate doses of the drug under the control of glycemia level, etiotropic antibiotic therapy, anticoagulants, and immunomodulators were prescribed according to the indications (Zimny et al., 2002;Duzgun et al., 2008;Falanga, 2005). Perfusion vascular therapy was prescribed to patients with the neuroischemic form of DFS. ...
Diabetes mellitus is currently characterised by a high progressive prevalence of patients. The purpose of this study is to evaluate the clinical, functional, and morphological parameters of purulonecrotic foci healing in diabetic foot syndrome (DFS) using programmable sanitation technologies. The patients were randomised into two groups. In the comparison group (n=51), patients received conventional local treatment after surgery. In the main group (n=55), after surgical treatment, the wound was sutured, and in the postsurgical period, programmable sanitation was conducted using the AMP-01 device. The cytological smears of the main group identified a higher rate of cellular reactions in the wound. There was a 1.3-fold reduction in the duration of hospitalisation, the number of purulent complications was significantly less (p=0.014). It was possible to preserve the supporting function of the foot in patients of the main group in a larger percentage of cases (p=0.023). There was a statistically significant increase in the frequency of high amputations in the comparison group (p=0.026). As a result, the effectiveness of the use of programmable sanitation technologies for purulent lesions of the diabetic foot has been proven.
... 8 Healing rates with standard of care vary from about 10-33% in patients after 12 weeks of care. [9][10][11] Given the low healing efficacy of standard of care and the significant economic and societal burden from DFUs, the potential for a novel, non-invasive treatment modality is intriguing. Repeated remote ischemic conditioning (rRIC) is one of these potential treatment modalities. 2 Initially, remote ischemic conditioning was studied for cardiovascular conditions and was typically applied in a single treatment session. ...
Patients with a diabetic foot ulcer (DFU) suffer disabilities and are at increased risk for lower extremity amputation. Current standard of care includes debridement, topical antibiotics, and weight off‐loading—still resulting in low rates of healing. Previous small‐scale research has indicated that repeated remote ischemic conditioning (rRIC) is a novel modality that delivers significantly higher DFU healing rates. This proof‐of‐concept study was performed to expand the research on the utility of rRIC as an adjunctive treatment in the healing of chronic DFUs. Forty subjects (41 wounds) received rRIC treatment three times weekly in addition to standard of care for 12 weeks. Subjects that did not heal in this time frame but had a significant reduction in wound size were eligible to continue for an 8‐week extension period. By the end of the extension period, 31 of the 41 DFU wounds (75.6%) in this study were determined to be healed. This compares favourably to the 25–30% standard of care average healing rate. For additional comparison, another group of patients receiving standard of care alone, by the same investigator, was selected and matched by wound size at baseline and wound location. For this matching cohort, after 20 weeks of treatment, only 15 of the 41 DFU comparison wounds (36.6%) were determined to be healed, in line with other standard of care results. In the rRIC treatment group, the 10 wounds that did not heal, experienced an average reduction in wound area of 54.3%. The results of this proof‐of‐concept study reinforce earlier evidence that the addition of rRIC to local wound care significantly improves the healing of chronic diabetic foot ulcers.
... Furthermore, the time scale of delayed healing in patient wounds can be orders of magnitude larger than what is typically observed in pre-clinical models, which is on the order of days-to-weeks, depending on the initial wound size, location, and species. 44 The validity of extrapolating our model predictions from the relatively rapidly healing murine wounds to the more slowly healing human wounds remains to be confirmed. ...
Introduction
Pharmacologic approaches for promoting angiogenesis have been utilized to accelerate healing of chronic wounds in diabetic patients with varying degrees of success. We hypothesize that the distribution of proangiogenic drugs in the wound area critically impacts the rate of closure of diabetic wounds. To evaluate this hypothesis, we developed a mathematical model that predicts how spatial distribution of VEGF-A produced by delivery of a modified mRNA (AZD8601) accelerates diabetic wound healing.
Methods
We modified a previously published model of cutaneous wound healing based on coupled partial differential equations that describe the density of sprouting capillary tips, chemoattractant concentration, and density of blood vessels in a circular wound. Key model parameters identified by a sensitivity analysis were fit to data obtained from an in vivo wound healing study performed in the dorsum of diabetic mice, and a pharmacokinetic model was used to simulate mRNA and VEGF-A distribution following injections with AZD8601. Due to the limited availability of data regarding the spatial distribution of AZD8601 in the wound bed, we performed simulations with perturbations to the location of injections and diffusion coefficient of mRNA to understand the impact of these spatial parameters on wound healing.
Results
When simulating injections delivered at the wound border, the model predicted that injections delivered on day 0 were more effective in accelerating wound healing than injections delivered at later time points. When the location of the injection was varied throughout the wound space, the model predicted that healing could be accelerated by delivering injections a distance of 1–2 mm inside the wound bed when compared to injections delivered on the same day at the wound border. Perturbations to the diffusivity of mRNA predicted that restricting diffusion of mRNA delayed wound healing by creating an accumulation of VEGF-A at the wound border. Alternatively, a high mRNA diffusivity had no effect on wound healing compared to a simulation with vehicle injection due to the rapid loss of mRNA at the wound border to surrounding tissue.
Conclusions
These findings highlight the critical need to consider the location of drug delivery and diffusivity of the drug, parameters not typically explored in pre-clinical experiments, when designing and testing drugs for treating diabetic wounds.
... There are various factors that contribute to the ulcer healing including glycated hemoglobin level and peak plantar pressure. Adequate levels of glycated hemoglobin is an important factor especially during the healing of an ulcer [12][13][14]. Other factors, including repetitive high plantar pressure, increased friction between foot and footwear, especially during walking activities, contribute to ulcer formation that can be reduced using appropriate insoles [15][16][17]. ...
Offloading plantar pressure in a diabetic foot with neuropathy is challenging in conventional clinical practice. Custom-made insole (CMI) materials play an important role in plantar pressure reduction, but the assessment is costly and time-consuming. Finite element analysis (FEA) can provide an efficient evaluation of different insoles on the plantar pressure distribution. This study investigated the effect of CMI materials and their combinations on plantar pressure reduction for the diabetic foot with neuropathy using FEA. The study was conducted by constructing a three-dimensional foot model along with CMI to study the peak contact pressure between the foot and CMI. The softer material (E = 5 MPa) resulted in a better reduction of peak contact pressure compared with the stiffer material (E = 11 MPa). The plantar pressure was well redistributed with softer material compared with the stiffer material and its combination. In addition, the single softer material resulted in reduced frictional stress under the first metatarsal head compared with the stiffer material and the combination of materials. The softer material and its combination have a beneficial effect on plantar pressure reduction and redistribution for a diabetic foot with neuropathy. This study provided an effective approach for CMI material selection using FEA.
... Another measurement technique, so-called acetate tracing, includes applying a sheet of clear acetate to the wound and delineating the borders, then placing the sheet on a graph paper, and counting the squares that are at least half within the surrounded area [13], [14]. Using the planimetric approach Zimny et al. [15] discusses the changes of the wound area or radius relatively to different wounds' etiologies. The results are usually highly accurate, however, this method is time-consuming (unless greater than 1-centimeter squares are used), inconvenient for the patient and staff, and also there is a risk of contamination of the treatment room. ...
With the aging population of the developed countries, the diseases of affluence become common. One of the consequences of their complications are chronic wounds that affect more and more people. Because the healing of chronic wounds is a lengthy process, its monitoring should be as simple as possible, yet providing accurate and reliable documentation. In this paper, we present an image acquisition system and wound surface reconstruction method using several imaging modalities: color photography, thermal imaging, and depth perception. The proposed method is dedicated mainly to wounds located on the limbs where body curvature is large, and its influence on 2D results cannot be neglected. Our approach minimizes the extra effort taken by the medical staff to prepare the wound outline as it is still performed using 2D color photo and then mapped into the 3D space. The method was validated on 29 data sets containing two 3D point clouds from two depth imaging devices (depth camera and stereo camera) as well as 2D color photos and thermal maps. The approach was compared with expert delineations as well as other contemporary methods for wound surface reconstruction presented in the literature. Performed experiments and the obtained results show that the proposed method is statistically concordant with expert delineations performed in 3D.
... Pemayun and Naibaho (2017) in an Indonesian study have reported a mean duration of diabetes to be 6.4 years which is lower than the finding of 8.5 years in our study, although lower than the >10 years reported in a Pakistan study (Mehmood et al. 2008). The average healing time of the ulcers were 51.7 days while neuro-ischemic ulcers had the longest healing time of 62.4 days which is lower than findings by Zimny et al. (2002) who have reported an average healing time of 77.9 days and 123.4 days for neuro- ischemic ulcers. This finding is not surprising considering the fact that wound healing in patients with diabetes can be difficult due to combination of factors like hyperglycemia, chronic inflammation, micro and macro-circulatory dysfunction, hypoxia, autonomic and sensory neuropathy, and impaired neuropeptide signaling (Baltzis et al. 2014). ...
Objective. The high amputation rates from diabetic foot ulcer (DFU) in Nigeria and prolonged hospitalization due to poor wound healing is a source of concern. Furthermore, factors that affect wound healing of DFUs have not yet been well studied in Nigeria, whereas knowing these factors could improve DFU outcomes. Therefore, the objective of this study was to determine the factors that are associated with the wound healing in patients hospitalized for DFU.
Methods. The Multi-Center Evaluation of Diabetic Foot Ulcer in Nigeria (MEDFUN) was an observational study involving 336 diabetic patients hospitalized for DFU and managed by a multi-disciplinary team until discharge or death. Demographic, clinical, and biochemical characteristics were documented. Test statistics used were chi square, t-test, univariate, and multivariate logistic regression. The study endpoints were ulcer healing, LEA, duration of hospitalization, and mortality. Here we present data on wound healing.
Results. The mean ± SD age was 55.9±12.5 years. Univariate predictors of wound healing were ulcer duration more than 1 month prior to hospitalization (p<0.001), peripheral arterial disease (PAD) (p<0.001), foot gangrene (p<0.001), Ulcer grade ≥3 (p=0.002), proteinuria (p=0.005), anemia (p=0.009), renal impairment (p=0.021), glycated hemoglobin ≥7% (0.012), and osteomyelitis (p<0.001). On multivariate regression, osteomyelitis was the strongest independent predictor of wound healing after adjusting for all other variables (OR 0.035; 95% CI 0.004–0.332). This was followed by PAD (OR 0.093; 95% CI 0.028–0.311), ulcer duration >1 month (OR 0.109; 95% CI 0.030–0.395), anemia (OR 0.179; 95% CI 0.056–0.571).
Conclusion. Presence of osteomyelitis, duration of ulcer greater than 1 month, PAD, Wagner grade 3 or higher, proteinuria, presence of gangrene, anemia, renal impairment, and HbA1c ≥7% were the significant predictors of wound healing in patients hospitalized for DFU. Early identification and prompt attention to these factors in a diabetic foot wound might significantly improve healing and reduce adverse outcomes such as amputation and death.
... Our average wound healing days of 42.6 ± 2.7 is much less than those reported in other studies. Average ulcer duration of 133 days had been reported in the literature [12]. The better result of our study might be due to the strict wound care protocol, followed at the institute, comprising a multidisciplinary team, involving physician, surgeon including plastic and vascular surgeon, podiatrist, special wound care nursing team, and specific consultancy for diet and life-style modification, including smoking cessation. ...
Diabetic foot ulcer (DFU) is the commonest condition for hospital admission and usually the starting point of most diabetic related lower limb amputations. Considering the significant role played by vascularity in the outcome of ulcer healing, we undertook this study to find out the comparative utility of commonly used vascular assessment methods. This study was a single center prospective non-randomized observational study, conducted for a period of 6 months, in diabetic patients presenting with foot ulcers of Wagner Grade II and III. The aim of our study was to compare the performances of ankle-brachial index (ABI) and transcutaneous partial pressure of oxygen (tcPO2) measurement in predicting wound healing in diabetic ulcers and to define the optimal cut-off value for Indian patients. Five hundred sixty-four patients were included in this study, with the mean age of 58 years. Eighty-seven patients (15%) had peripheral arterial occlusive disease. Four hundred seventy ulcers (83%) healed with the mean healing days of 42.6 days. Age, duration of diabetes, serum creatinine level, and presence of infection were the factors with negative impact in wound healing. In our study, ABI value of 0.6 was found to have 100% sensitivity and 70% specificity, and tcPO2 value of 22.5 was found to have 75% sensitivity and 100% specificity in predicting wound healing. Both ABI and tcPO2 are complementary, but tcPO2 is a better predictor for amputation while ABI is a better predictor for ulcer healing. While assessing the ischemic status of foot ulcer, the cut-off values should be higher in diabetics than non-diabetics.
... Time to complete ulcer healing by conventional dressings according to multiple RCTs and prospective studies range between 59 to 133 days. [7][8][9] NPWT is an effective treatment modality in chronic diabetic ulcers as shown in our study with reduction in duration of complete ulcer healing by at least 25%. ...
Background: Chronic ulcers in patients with diabetes are complex and treatment is often difficult. At the moment, negative pressure wound therapy (NPWT) is widely used for the treatment of several types of wounds. Nevertheless, the clinical evidence to support the application of this dressing in chronic diabetic ulcers is scarce. The aim of this study was to evaluate the efficacy of NPWT to treat chronic diabetic ulcers.Methods: Prospective time bound comparative study. Diabetic patients aged 18 years or older with an ulcer were assigned to treatment with NPWT. Primary efficacy end point was time in reaching complete ulcer closure. A size of sample of 15 patients was used. NPWT was prepared with a polyurethane foam dressing, a Silicone catheter, a transparent adhesive drape and continuous negative pressure of 125 mm Hg. The wound was treated for cycles of 5 days and evaluated at every dressing change. Descriptive and analytical statistics were used.Results: There were 15 patients, with a mean age of 54.4 years (73.3% men). The average time to complete ulcer closure was (41.2 [8.5] days).Conclusions: NPWT is an effective modality of treatment of chronic diabetic ulcers with early appearance of granulation tissue and faster rates of overall complete wound closure.
... Central I diabetes is most prevalent in non-hispanic whites and Type II mainly occurs in minority populations (African Americans, Hispanic/Latino Americans and American; NIDDK-NDIC). In addition to blindness, kidney disease, heart disease and stroke, it is notable that 60% of non-traumatic lower limb amputations, due to critical limb ischemia occur in the diabetic population [1][2][3]. Amputation is 15 times more common in diabetics followed by a 50% death rate. Etiologically, ulcers due to occluded arterioles causing insufficiency in arterial flow are a consequence of cardiovascular disease of Type I diabetics while neuro ischemic and neuropathic DFUs occur in both Type I and Type II diabetics. ...
... Central I diabetes is most prevalent in non-hispanic whites and Type II mainly occurs in minority populations (African Americans, Hispanic/Latino Americans and American; NIDDK-NDIC). In addition to blindness, kidney disease, heart disease and stroke, it is notable that 60% of non-traumatic lower limb amputations, due to critical limb ischemia occur in the diabetic population [1][2][3]. Amputation is 15 times more common in diabetics followed by a 50% death rate. Etiologically, ulcers due to occluded arterioles causing insufficiency in arterial flow are a consequence of cardiovascular disease of Type I diabetics while neuro ischemic and neuropathic DFUs occur in both Type I and Type II diabetics. ...
A topical wound healing agent that could counter act the specific defects that prevent the healing of wounds sustained as a consequence of diabetes would be the first successful treatment for this serious unmet medical need. The application of calreticulin (CRT) to a porcine model of impaired wound healing surpassed, by far, Regranex®, the only current topical agent approved for the treatment of diabetic foot ulcers (DFUs). Whereas Regranex only affects dermal healing, CRT targets both epidermal resurfacing and dermal tissue regeneration. Moreover, CRT exerted an identical vulnerary effect in a diabetic mouse (db/ db) wound healing model. In vitro studies confirmed the diverse and broad-reaching biological effects of CRT at the cellular level. Exogenous CRT promoted directed cellular migration of human keratinocytes, macrophages, and fibroblasts, stimulated proliferation of keratinocytes and fibroblasts, and induced fibroblasts to synthesize the extracellular matrix (ECM) proteins, collagen, fibronectin, and elastin. In addition, CRT induced a5 integrin likely for migration on matrix.CRT also enhances the immune response. Importantly, as lack of recruitment of cells required for healing, acellular wounds, and a paucity of granulation tissue epitomizes chronic DFUs, CRT could be the first biotherapeutic to specifically attack the problems that characterize diabetic wounds, suffered by close to 4 million people in the United States and 30 million globally, with increased risk of amputation and death. This article presents proof of principle in vivo and extensive in vitro data to support a novel role for the heretofore intracellular ER chaperone protein, CRT, as a diversely functional biotherapeutic for DFUs and other chronic wounds.
... It has been reported in the literature that, providing standard care, the time course of wound-healing in diabetic foot ulcers is predominantly determined by etiologic factors, and to a lesser degree by wound size. 26 However, both the patient's health condition and the wound shape have been invoked to explain differences in healing rates. 14,15,17 In this study, null or weak correlations have been found between D c or D avg in terms of wound size and shape, parameterized by means of A, P, and S c , or with the patient's condition. ...
The incidence of ulcers associated to type 2 diabetes mellitus (T2DM) increases every year. We introduce and explore a new mathematical algorithm to evaluate wound-healing in foot ulcers associated to T2DM. Fifteen patients (nine women and six men), mean age of 70 ± 16 years were included. The evolution of their wounds followed-up for a period of 18–45 days. According to the Wagner grading system the ulcers were grade I (5 patients), grade II (9 patients), and grade III (1 patient). Clinically, the type of the ulcers was neuroischemic (12 patients) and neuropathic (3 patients). A new parameter is introduced, the “continuous linear healing rate” Dc that was more accurate with higher values and requires less quantifications than usual formulas to make a wound-healing projection.
... The recovery trajectory of a diabetic foot ulcer is largely dependent on foot self-care and adherence to treatment regimens. On average, a diabetic foot ulcer takes 133 days to heal [5]. Those who do not adhere well to foot treatment may obtain a chronic ulcer and/or one that may worsen to the point of amputation. ...
Aims:
This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) in patients with a diabetic foot ulcer increased decision self-efficacy and foot treatment adherence.
Methods:
Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decisional conflict and decision regret.
Results:
Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation.
Conclusions:
An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. This article is protected by copyright. All rights reserved.
... • Steeper initial conditions (as in a deep wound) lead to slower capillary regeneration; this is reasonable, since smaller/shallower wounds are expected to heal faster [106,119] (see also [70] for burn depth). In the deep wound case we also observe a marked difference in behaviour between the two hypotheses: the selforganising case exhibits a very slow progression for values of ξ not close to 1, with the empirically observed speed occurring for ξ = 1; by contrast, the sprouting hypothesis predicts lymphangiogenesis to take place from left to right at a speed that increases with ξ up to ξ ≈ 0.9775, when it becomes symmetric; for larger ξ healing switches to a right-to-left process, at decreasing speed as ξ approaches 1. ...
Several studies suggest that one possible cause of impaired wound healing is failed or insufficient lymphangiogenesis, that is the formation of new lymphatic capillaries. Although many mathematical models have been developed to describe the formation of blood capillaries (angiogenesis), very few have been proposed for the regeneration of the lymphatic network. Lymphangiogenesis is a markedly different process from angiogenesis, occurring at different times and in response to different chemical stimuli. Two main hypotheses have been proposed: 1) lymphatic capillaries sprout from existing interrupted ones at the edge of the wound in analogy to the blood angiogenesis case; 2) lymphatic endothelial cells first pool in the wound region following the lymph flow and then, once sufficiently populated, start to form a network. Here we present two PDE models describing lymphangiogenesis according to these two different hypotheses. Further, we include the effect of advection due to interstitial flow and lymph flow coming from open capillaries. The variables represent different cell densities and growth factor concentrations, and where possible the parameters are estimated from biological data. The models are then solved numerically and the results are compared with the available biological literature.
... Foot ulcers take a notoriously long time to heal: the International Working Group on the Diabetic Foot reports a mean healing time of 6 months for diabetic foot ulcers [29]. The foot ulcer healing time reported in many studies varies widely depending on the patients' characteristics [30,31] and in particular were different for patients with neuropathic or ischaemic ulcers [16,32]. This is probably because in diabetic patients revascularisation can restore normal blood flow in the large vessels, including the pedal arteries, but cannot restore normal microvascular flow [33][34][35]. ...
Aims/hypothesis
We investigated the significance of microangiopathy in the development of foot ulcer, which is still disputed.
Methods
We assessed microangiopathy by histological analysis of the capillary ultrastructure using transmission electron microscopy and capillary density and arteriolar morphology in paraffin-embedded sections from the skin of type 2 diabetic patients: 30 neuroischaemic patients (Isc) revascularised with peripheral angioplasty and 30 neuropathic patients (Neu) with foot ulcer, compared with ten non-diabetic volunteers.
Results
In the diabetic patients, capillaries in the dermal papillary layer were fewer (−22.2%, 159 ± 43 vs 205 ± 52 mm2 in non-diabetic volunteers, p < 0.01). They also showed detrimental remodelling, with a 2.2-fold increase in capillary basement membrane thickness (3.44 ± 1.19 vs 1.53 ± 0.34 μm in non-diabetic volunteers, p < 0.001) and a 57.7% decrease in lumen area (14.6 ± 11.1 vs 34.7 ± 27.5 μm2, p < 0.001). No differences were observed between the diabetic Isc or Neu patients. Isc were more prone to develop arteriolar occlusion than Neu (16.8 ± 6.9% vs 6.7 ± 3.7%, respectively, p < 0.001). No patient had been amputated at 30 days and healing time was significantly longer in Isc (180 ± 120 vs 64 ± 50 days in Neu, p < 0.001).
Conclusions/interpretation
Capillary microangiopathy is present in equal measure in neuroischaemic and neuropathic diabetic foot skin. The predominance of arteriolar occlusions with neuroischaemia indicated the existence of an additional ‘small vessel disease’ that did not affect an effective revascularisation and did not worsen the prognosis of major amputations but slowed the healing process of the neuroischaemic foot ulcer.
Trial registration:
ClinicalTrials.gov NCT02610036.
This commentary considers the similarities which exist between pressure ulcers (PUs) and diabetic foot ulcers (DFUs). It aims to describe what is known to be shared—both in theory and practice—by these wound types. It goes on to detail the literature surrounding the role of inflammation in both wound types. PUs occur following prolonged exposure to pressure or pressure in conjunction with shear, either due to impaired mobility or medical devices. As a result, inflammation occurs, causing cell damage. While DFUs are not associated with immobility, they are associated with altered mobility occurring as a result of complications of diabetes. The incidence and prevalence of both types of lesions are increased in the presence of multimorbidity. The prediction of either type of ulceration is challenging. Current risk assessment practices are reported to be ineffective at predicting when ulceration will occur. While systemic inflammation is easily measured, the presence of local or subclinical inflammation is harder to discern. In patients at risk of either DFUs or PUs, clinical signs and symptoms of inflammation may be masked, and systemic biomarkers of inflammation may not be elevated sufficiently to predict imminent damage until ulceration appears. The current literature suggests that the use of local biomarkers of inflammation at the skin's surface, namely oedema and temperature, may identify early tissue damage.
Diabetic foot ulcers (DFUs) pose a critical medical challenge, significantly im-pairing the quality of life of patients. Adipose-derived stem cells (ADSCs) have been identified as a promising therapeutic approach for improving wound healing in DFUs. Despite extensive exploration of the mechanical aspects of ADSC therapy against DFU, its clinical applications remain elusive. In this review, we aimed to bridge this gap by evaluating the use and advancements of ADSCs in the clinical management of DFUs. The review begins with a discussion of the classification and clinical management of diabetic foot conditions. It then discusses the current landscape of clinical trials, focusing on their geographic distribution, reported efficacy, safety profiles, treatment timing, administration techniques, and dosing considerations. Finally, the review discusses the preclinical strategies to enhance ADSC efficacy. This review shows that many trials exhibit biases in study design, unclear inclusion criteria, and intervention protocols. In conclusion, this review underscores the potential of ADSCs in DFU treatment and emphasizes the critical need for further research and refinement of therapeutic approaches, with a focus on improving the quality of future clinical trials to enhance treatment outcomes and advance the field of diabetic wound care.
Introduction: Chronic wounds caused by diabetes or lower-extremity artery disease are intractable because the wound healing mechanism becomes ineffective due to the poor environment of the wound bed. Biosheets obtained using in-body tissue architecture (iBTA) are collagen-based membranous tissue created within the body and which autologously contain various growth factors and somatic stem cells including SSEA4-posituve cells. When applied to a wound, granulation formation can be promoted and epithelialization may even be achieved. Herein, we report our clinical treatment experience with seven cases of intractable diabetic foot ulcers. Cases: Seven patients, from 46 to 93 years old, had large foot ulcers including in the heel area, which were failing to heal with standard wound treatment. Methods: Two or four Biosheet-forming molds were embedded subcutaneously in the chest or abdomen, and after 3 to 6 weeks, the molds were removed. Biosheets that formed inside the mold were obtained and applied directly to the wound surface. Results: In all cases, there were no problems with the mold’s embedding and removal procedures, and Biosheets were formed without any infection or inflammation during the embedding period. The Biosheets were simply applied to the wounds, and in all cases they adhered within one week, did not fall off, and became integrated with the wound surface. Complete wound closure was achieved within 8 weeks in two cases and within 5 months in two cases. One patient was lost due to infective endocarditis from septic colitis. One case required lower leg amputation due to wound recurrence, and one case achieved wound reduction and wound healing in approximately 9 months. Conclusions: Biotubes obtained via iBTA promoted wound healing and were extremely useful for intractable diabetic foot ulcers involving the heel area.
Objective
To evaluate the efficacy of treatment of hard-to-heal wounds of patients with ischaemia of the lower extremities, and compare an omega-3 wound matrix product (Kerecis, Iceland) with a standard dressing.
Method
A single-centre, prospective, randomised, controlled clinical trial of patients with hard-to-heal wounds following three weeks of standard care was undertaken. The ischaemic condition of the wound was confirmed as a decreased transcutaneous oxygen pressure (TcPO 2 ) of <40mmHg. After randomising patients into either a case (omega-3 dressing) or a control group (standard dressing), the weekly decrease in wound area over 12 weeks and the number of patients that achieved complete wound closure were compared between the two groups. Patients with a TcPO 2 of ≤32mmHg were taken for further analysis of their wound in a severe ischaemic context.
Results
A total of 28 patients were assigned to the case group and 22 patients to the control group. Over the course of 12 weeks, the wound area decreased more rapidly in the case group than the control group. Complete wound healing occurred in 82% of patients in the case group and 45% in the control group. Even in patients with a severe ischaemic wound with a TcPO 2 value of <32 mmHg, wound area decreased more rapidly in the case group than the control group. The proportions of re-epithelialised area in the case and control groups were 80.24% and 57.44%, respectively.
Conclusion
Considering the more rapid decrease in wound area and complete healing ratio in the case group, application of a fish skin-derived matrix for treating lower-extremity hard-to-heal wounds, especially with impaired vascularity, would appear to be a good treatment option.
This study aimed to evaluate the clinical evolution of patients with diabetic foot ulcer treated with antimicrobial photodynamic therapy (aPDT) using the Bates‐Jensen (BJ) scale. A total of 21 patients were monitored, with an average age of 58 years. Patients underwent the standard treatment protocol of the institution, supplemented with aPDT utilizing 0.01% methylene blue (MB) and laser irradiation (660 nm, 100 mW, 6 J per point). Following aPDT, the lesions were protected with hydrofiber dressings containing silver. The Bates‐Jensen Scale was employed at pre‐treatment and post‐aPDT sessions to assess lesion progression. The results demonstrated a significant difference between pre‐ and post‐treatment values in the overall BJ score. The use of MB in aPDT proved to be an effective, safe, well‐tolerated treatment with high patient adherence and the potential for implementation in the care of diabetic foot conditions.
Aims:
This study aimed to identify demographic, clinical, and psychological contributors to DFU healing and favorable healing process.
Methods:
Patients with a chronic DFU were evaluated at baseline (T0; n = 153), two months later (T1; n = 108), and six months later (T2; n = 71). Patients were evaluated on health literacy, perceived stress, anxiety, depression, and illness perceptions. Cox proportional hazard models were built to analyze the predictors of DFU healing and favorable healing process (wound area reduction) including the assessment of time to achieve those outcomes.
Results:
More than half of patients had their DFU healed (56.1%) or showed a favorable healing process (83.6%). Median time for healing was 112 days, while for favorable process was 30 days. Illness perceptions were the only predictor of wound healing. Female gender, adequate health literacy, and being the first DFU predicted a favorable healing process.
Conclusions:
This is the first study showing that beliefs about DFU are significant predictors of DFU healing, and that health literacy is a significant predictor of a favorable healing process. Brief, comprehensive interventions should be implemented, at the treatment initial stage, in order to change misperceptions and to promote DFU literacy and better health outcomes.
Objectives
The objective of this study was to evaluate the immediate effect of manual therapy on ankle joint mobility and static balance in patients with diabetes.
Methods
Forty patients, at a mean age of 59.35 ± 7.85, with type 2 diabetes mellitus and neurologic symptoms according to a Neuropathy Symptom Score protocol with amplitude, were included. The patients were divided into 2 groups: sham group and intervention group, which underwent manual manipulation intervention and 7-day follow-up. Joint range-of-motion analysis was performed using digital goniometry and static discharge of weights assessed by computerized baropodometry with open and closed eyes. The Shapiro-Wilk normality test was used to analyze the distribution. The data showed normal distribution, so the analysis of variance tests followed by Tukey's tests were used. SAS statistical software was used and the significance level was 5%.
Results
The results of the intervention group showed an increase in the variable ankle goniometry over time compared to the sham group. The dorsiflexion movement on the right side obtained major gains over time; in addition, plantar flexion increased.
Conclusion
Based on the participants evaluated in this study, manual therapy increased the ankle joint amplitude and improved the static balance in individuals with diabetes.
Chronic wounds are a major health problem that cause the medical infrastructure billions of dollars every year. Chronic wounds are often difficult to heal and cause significant discomfort. Although wound specialists have numerous therapeutic modalities at their disposal, tools that could 3D-map wound bed physiology and guide therapy do not exist. Visual cues are the current standard but are limited to surface assessment; clinicians rely on experience to predict response to therapy. Photoacoustic (PA) ultrasound (US) is a non-invasive, hybrid imaging modality that can solve these major limitations. PA relies on the contrast generated by hemoglobin in blood which allows it to map local angiogenesis, tissue perfusion and oxygen saturation—all critical parameters for wound healing. This work evaluates the use of PA-US to monitor angiogenesis and stratify patients responding vs. not-responding to therapy. We imaged 19 patients with 22 wounds once a week for at least three weeks. Our findings suggest that PA imaging directly visualizes angiogenesis. Patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase (p = 0.002). These responders had a significant and negative correlation between PA intensity and wound size. Hypertension was correlated to impaired angiogenesis in non-responsive patients. The rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring (power = 88%, alpha = 0.05) This early response detection system could help inform management and treatment strategies while improving outcomes and reducing costs.
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Objective
To assess the effects of the primary prevention and the healing of diabetic foot ulcers at Diabetic Foot Clinic at a university hospital in Thailand.
Study design
Prospective descriptive study.
Methods
Diabetic patients with diabetic foot ulcers or pre-ulcerative lesions who regularly were followed at the outpatient Diabetic Foot Clinic, were recruited. The data were collected prospectively. Prevention and healing of diabetic foot ulcers were assessed and measured.
Results
Thirty-five diabetic patients with diabetic foot ulcers (n = 21) and pre-ulcerative lesions (n = 28) were recruited. Weekly wound radius reduction was 1.1 ± 1.1 (mean ± SD) mm/week. Fifty-seven percent of the ulcers achieved the surrogate 50% area reduction within 4 weeks. The percentage of healed ulcers at 12 and 16 weeks were 38.1%, and 47.6%, respectively. The percentage of improvement of the pre-ulcerative lesion was 78.6%. The most common complication was soft tissue infection (19%) which required surgical debridement (14.2%) and minor amputation (4.8%).
Conclusion
The effectiveness of the Diabetic Foot Clinic was assessed by the reduction of the ulcer radius, ability to reach the surrogate 50% area reduction, and the improvement of the pre-ulcerative lesion. The weekly reduction of the ulcer radius was 1.1 ± 1.1 mm/week. The percentage of reaching the surrogate 50% area reduction within 4 weeks was 57%. The percentage of improvement of the pre-ulcerative lesion was 78.6%.
Aging, exposure to oxidants, infectious pathogens, inflammogens, ultraviolet radiation and other environmental and genetic factors can result in the development of various skin disorders. Despite immense progress being made in dermatological treatments, many skin-associated problems still remain difficult to treat and various therapies have limitations. Progress in silica-based nanomaterials research provides an opportunity to overcome these drawbacks and improve therapies and is a promising tool for inclusion in clinical practice to treat skin diseases. This review focuses on the use of various types of silica nanoparticles with therapeutic applications in various skin disorders. These nanosystems improve treatment efficacy by maintaining or enhancing the effect of several drugs and are useful tools for nanomedicine, pharmaceutical sciences and future clinical applications.
Diabetic foot ulcers (DFUs) are estimated to cost around £1
billion per year in the NHS alone (Kerr, 2017; Guest et al, 2018)
and represent a significant health challenge in the UK and
worldwide. Central to tackling the impact of DFUs in the UK is
the implementation of evidence-based practice.
A group of experts met to discuss the burden of DFUs and
the challenges facing service delivery of DFU care in the UK.
Based on their discussions and findings from the EXPLORER
study (Edmonds et al, 2018), the group recommended
adding evidence-based local wound care as a new pillar to
DFU standard of care. A fast-track pathway for diabetic foot
ulceration for implementation in the UK was also developed
using the UrgoStart (TLC-NOSF) range as part of the standard
of care.
The goal of this document is to provide clinicians with
information and recommendations to improve healing rates and
reduce healing time of DFUs.
Objective:
Wound dressings that use biosynthetic cellulose may be a good alternative to dressings currently used to treat chronic and acute ulcers because their nanostructure is similar to collagen. The objective of this study was to evaluate a wound dressing created with a new material that is composed of a fibrillary network of biosynthetic cellulose.
Methods:
A case series of 8 patients in primary healthcare centers in Östergötland county council, Sweden, with chronic and acute lower limb wounds were treated with a wound dressing based on eiratex (S2Medical AB, Linköping, Sweden). The dressing was applied to traumatic (n = 5) and venous ulcers (n = 3). All ulcers were considered healed at the end of the treatment.
Main outcome measure:
The wounds were examined at regular intervals by a physician to determine healing time, number of dressing changes, and number of visits.
Main results:
Mean healing time was 43 ± 6 days after the first application of the dressing. The mean number of visits was 5.7 ± 0.6, and the mean number of dressings used per patient was 1.7 ± 0.2.
Conclusions:
These results demonstrate the efficacy of a wound dressing made of eiratex to heal chronic and acute ulcers. The data show that the number of dressings used and dressing changes needed to heal the ulcers are lower than what have been reported in the literature for other dressing materials.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Introduction
Since their release, prosthetic feet with integrated hydraulic ankle units have proved a popular prescription choice among individuals with lower-limb amputation. This study evaluates the effect of including this type of prosthetic foot on the peak plantar pressures of the patient’s contralateral foot.
Case Description and Methods
Peak plantar pressures of 14 participants with established K3 activity levels were measured before and after the addition of a prosthetic foot with hydraulic ankle unit using the Amcube pressure plate.
Results
The results showed a statistically significant reduction in contralateral peak plantar pressures with the use of a prosthetic foot containing a hydraulic ankle unit.
Conclusions
The benefits of changing to a prescription including a foot with integrated hydraulic ankle unit can have significant effects on the forces acting on the remaining foot of an individual with amputation.
Introductions
The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing. The aim of this study was to report the cumulative experience of three centers for vascular surgery regarding use of the Omega3 Wound matrix in selected patients with complicated wounds.
Material and methods
In this study 23 patients with 25 vascular and/or diabetes mellitus-associated complicated wounds and partially exposed bony segments were treated with the Omega3 Wound matrix in three vascular centers. In several patients conventional wound treatment with vacuum therapy had previously been carried out sometimes over several weeks without durable success. Following initial debridement in the operating room, the matrix was applied and covered with a silicone mesh. In the further course, wound treatment was conducted on an outpatient setting if possible.
Results
In total 25 wounds were treated with localization at the level of the thigh (n = 2), the distal calf (n = 7), the forefoot (n = 14) and the hand (n = 2). The time to heal varied between 9 and 41 weeks and between 3 and 26 wound matrices were applied per wound. Interestingly, a reduction of analgetics intake was noted when the treatment with the Omega3 Wound matrix was initiated.
Conclusions
The novel Omega3 Wound matrix in this study represented an effective treatment option in 25 complicated wounds. Further studies are necessary to evaluate the impact of the wound matrix on stimulation of granulation tissue and re-epithelialization as well as the potential antinociceptive and analgetic effects.
Background:
Foot ulcers are a disabling complication of diabetes that affect 15% to 25% of people with diabetes at some time in their lives. Phototherapy is a relatively new, non-invasive, and pain-free treatment method, which promotes the ulcer repair process through multiple mechanisms such as increased cell growth and vascular activity. Phototherapy may be used as an alternative approach for the treatment of foot ulcers in people with diabetes, but the evidence for its effect compared with placebo or other treatments has not yet been established.
Objectives:
To assess the effects of phototherapy for the treatment of foot ulcers in people with diabetes.
Search methods:
We searched the Cochrane Wounds Specialised Register (11 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 10), Ovid MEDLINE (11 October 2016), Ovid MEDLINE (In-Process & Other Non-Indexed Citations) (11 October 2016), Ovid Embase (11 October 2016), EBSCO CINAHL Plus (11 October 2016), and China National Knowledge Infrastructure (24 June 2017). We also searched clinical trials registries for ongoing and unpublished studies on 24 June 2017, and screened reference lists to identify additional studies. We used no restrictions with respect to language, date of publication, or study setting.
Selection criteria:
Randomised controlled trials or cluster randomised controlled trials that 1) compared phototherapy with sham phototherapy, no phototherapy, or other physical therapy modalities, 2) compared different forms of phototherapy, or 3) compared phototherapy of different output power, wavelength, power density, or dose range, in adults with diabetes and an open foot ulcer of any severity, in any setting.
Data collection and analysis:
Two review authors independently performed study selection, data extraction, and 'Risk of bias' assessment. We combined the study outcomes when appropriate.
Main results:
Eight trials with 316 participants met the inclusion criteria. Most of the included studies were single-centre studies that were carried out in clinics or hospitals with a sample size ranging from 14 to 84. We generally considered the included studies to be at unclear or high risk of bias, as they had one domain at high risk of bias, or three or more domains at unclear risk of bias.We did not identify any studies that reported valid data for time to complete wound healing. Meta-analysis of four studies including 116 participants indicated that participants receiving phototherapy may experience a greater proportion of wounds completely healed during follow-up compared with those receiving no phototherapy/placebo (64.5% for the phototherapy group versus 37.0% for the no phototherapy/placebo group; risk ratio 1.57, 95% confidence interval 1.08 to 2.28; low-quality evidence, downgraded for study limitations and imprecision). Two studies mentioned adverse events in the results; one study with 16 participants suggested that there were no device-related adverse events, and the other study with 14 participants suggested that there was no clear difference between phototherapy and placebo group.Four studies reported change in ulcer size, but primarily due to high heterogeneity, they were not combined. Results from individual trials (including 16 participants to 84 participants) generally suggested that after two to four weeks of treatment phototherapy may result in a greater reduction in ulcer size but the quality of the evidence was low due to unclear risk of bias in the original trial and small sample size. We based the analyses for quality of life and amputations on only one study each (28 participants and 23 participants respectively); both outcomes showed no clear difference between the phototherapy group and the no phototherapy/placebo group.
Authors' conclusions:
This systematic review of randomised trials suggested that phototherapy, when compared to no phototherapy/placebo, may increase the proportion of wounds completely healed during follow-up and may reduce wound size in people with diabetes, but there was no evidence that phototherapy improves quality of life. Due to the small sample size and methodological flaws in the original trials, the quality of the evidence was low, which reduces our confidence in these results. Large, well-designed randomised controlled trials are needed to confirm whether phototherapy could be an effective option for the treatment of foot ulcers in people with diabetes.
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of phototherapy for the treatment of foot ulcers in people with diabetes.
Die Diagnostik des diabetischen Fußes muss interdisziplinär erfolgen. Hier gehen Diabetologie, Angiologie und Neurologie Hand in Hand. Neben der Beschreibung des Status des Lokalbefundes ist die Evaluation einer begleitenden Neuropathie ebenso wichtig wie der Gefäßstatus, sodass vor allen invasiven Maßnahmen eine entsprechende Gefäßrekonstruktion erfolgt. Dritte Komponente im Rahmen der diagnostischen Sicherung ist der Status der Infektsituation, da der nicht adäquat behandelte Infekt ein hohes Risikopotential für eine nachfolgende Major-Amputation beinhaltet. Sofern die Diagnostik bereits auf diese drei Hauptaspekte des diabetischen Fußes fokussiert ist, ergeben sich Vorteile für die Therapieplanung und für das Outcome des Patienten.
The purpose of this study was to analyze long-term costs for foot ulcers in diabetic patients. Patients were treated and followed prospectively by a foot care team. A retrospective economic analysis was performed of costs for 274 patients during 3 years from healing of an initial foot ulcer, with or without amputation. Costs were estimated for inpatient care, outpatient care, home care, and social service. The cost calculations include costs due to complications and disability related to the initial ulcer, costs related to recurrence of ulcer, and costs for prevention of new ulcers.
Expected total present value cost per patient during 3 years of observation was 16,100 for primary healed patients without critical ischemia. For patients who healed with an amputation, the corresponding costs were 63,100 after a major amputation.
When estimating the costs for diabetic foot ulcers, it is not sufficient to calculate short-term costs. Long-term costs are high, mainly due to the need for increased home care and social service, but also due to costs for recurrent ulcers and new amputations.
To describe the relative contributions of neurological and vascular abnormalities to the overall risk of diabetic foot ulceration.
A case-control study of diabetic veterans from the Seattle Veterans Affairs Medical Center was conducted using data collected from 46 patients with diabetic foot ulcers and 322 control subjects. Neuropathy was determined by vibratory, monofilament, and tendon reflex testing. Macrovascular disease was measured by ankle-arm blood pressure index, and cutaneous perfusion was measured by transcutaneous oxygen tension (TcPO2) on the dorsal foot. A multivariate logistic regression model was used to adjust for confounding variables and to calculate the odds ratios (ORs) for each independent risk factor.
Three variables were significant independent predictors of foot ulceration: absence of Achilles tendon reflexes (adjusted OR 6.48, 95% confidence interval [CI] 2.37-18.06), insensate to the 5.07 monofilament (adjusted OR 18.42, 95% CI 3.83-88.47), and TcPO2 < 30 mmHg (adjusted OR 57.87, 95% CI 5.08-658.96). Absent vibratory sensation and low ankle-arm blood pressure index were not significant independent risk factors.
Both neuropathy and vasculopathy are strong independent risk factors for the development of diabetic foot ulcers. In our model, the strongest risk factor is impaired cutaneous oxygenation. However, in the clinical setting, sensory examination with a 5.07 monofilament probably remains the single most practical measure of risk assessment.
Fifteen percent of individuals with diabetes will likely develop foot ulcers in their lifetime, and approximately 15% to 20% of these ulcers are estimated to result in lower extremity amputation. Techniques to prevent lower extremity amputation range from the simple but often neglected foot inspection to complicated vascular and reconstructive foot surgery. Appropriate management can prevent and heal diabetic foot ulcers, thereby greatly decreasing the amputation rate and medical care costs. Prevention is the key to treatment. The author discusses general guidelines for foot screening and identifies three specific goals for prevention of amputation: 1) identification of at risk individuals needing prevention and the specific factors placing them at risk; 2) protection of the foot against the adverse effects of external forces (pressure, friction, and shear); and 3) reduction of the incidence of diabetic foot ulcers through educational programs.
Healing of foot ulcers is limited by multiple factors that necessitate a multifactorial and multidiciplinary approach. Patients with diabetes with previous foot ulcers have a high risk for new ulcerations and further amputations and have increased mortality rates. These findings stress the need for lifelong observation of the diabetic foot. The diabetic foot is a large economic problem, and management of ulcers has not always been performed in a most cost-effective way. Cost for amputation is high to society because of prolonged hospitalization, rehabilitation, and need for home care and social service for disabled patients. A cost-effective management plan should focus not only on short-term cost until healing but also on long-term costs, because foot ulcer and especially amputation are related to increased high reulceration rate and lifelong disability. The most important action to reduce cost in management of the diabetic foot is to avoid amputations.
The aim of the study was to determine the percentage of individuals with neuropathic diabetic foot ulcers receiving good wound care who heal within a defined period of time.
We conducted a systematic review of the control groups of clinical trials that evaluated a treatment for diabetic neuropathic foot ulcers. The meta-analytic techniques used include an estimation of the weighted mean percentage healed by end point, an evaluation of the homogeneity of trials, and an estimate of the 95% CI of the grouped data. Grouped-data univariate and multivariate logistic regression was conducted to assess the impact of mean age, ulcer size, and duration on the percentage of ulcers healed at end point.
We found a total of 10 control groups meeting our criteria. Six control groups used 20 weeks as the end point for healing or nonhealing. For the six control arms with a 20-week end point, we found a weighted mean healing rate of 30.9% (95% CI 26.6-35.1). A similar analysis for the four 12-week arms found a mean healing rate of 24.2% (19.5-28.8). We failed to detect any statistically significant heterogeneity for either the 20-week or the 12-week trials.
After 20 weeks of good wound care, approximately 31% of diabetic neuropathic ulcers heal. Similarly, after 12 weeks of good care, approximately 24% of neuropathic ulcers attain complete healing. Further patient-level analyses are necessary to definitively determine the associations of age, wound size, and wound duration with likelihood of healing.
The present study was undertaken to compare the predictive values of transcutaneous oxygen tension (TcPO2) and toe blood pressure (TBP) measurements for ulcer healing in patients with diabetes and chronic foot ulcers.
Investigated prospectively were 50 diabetic patients (37 men) with chronic foot ulcers. The age was 61 +/- 12 (mean +/- SD), and the diabetes duration was 26 +/- 14 years. TBP (mmHg) was measured in dig I and TcPO2 (mmHg) at the dorsum of the foot. Ulcer healing was continuously evaluated by measuring the ulcer area every 4-6 weeks. After a follow-up time of 12 months, the patients were divided into three groups according to clinical outcome: healed with intact skin, improved ulcer healing, or impaired ulcer healing.
Of the 13 patients who deteriorated, 11 had TcPO2 < 25 mmHg, while 34 of the 37 patients who improved had TcPO2 > or = 25 mmHg. The sensitivity and specificity for TcPO2 were 85 and 92%, respectively, when a cutoff level of 25 mmHg was used for determination of outcome of ulcer healing (healing or nonhealing). The corresponding values for TBP at 30 mmHg were 15 and 97%. Measurement of TcPO2 provided a higher positive predictive value (79%) than TBP (67%).
The results indicate that TcPO2 is a better predictor for ulcer healing than TBP in diabetic patients with chronic foot ulcers, and that the probability of ulcer healing is low when TcPO2 is < 25 mmHg.
The natural history of tissue repair and the critical determinants of faulty healing of diabetic ulcers remain obscure despite recent advances in our knowledge of the cellular physiology of normal cutaneous healing. To characterize the chronology and identify important factors affecting healing, we applied an objective method to quantify the rate of wound healing of full-thickness lower-extremity ulcers in 46 diabetic outpatients who received local wound care under a standardized clinical protocol. The initial ulcer healing rate, eventual status of tissue repair, and definitive clinical outcome were not significantly associated with age; diabetes type, duration, or treatment; level or change in glycosylated hemoglobin; current smoking; presence of sensory neuropathy; ulcer location or class; initial infection; or frequency of recurrent infections. However, direct measures of local cutaneous perfusion, estimated by periwound measurements of transcutaneous O2 tension (TcPo2) and transcutaneous CO2 tension (TcPco2), were significantly associated with the initial rate of tissue repair (P = 0.003 and 0.005, respectively). The strong prediction of early healing by these parameters of local skin perfusion was independent from the effects of segmental Doppler arterial blood pressure at the dorsalis pedis, although eventual ulcer reepithelialization was significantly related to foot blood pressure and periwound TcPo2 and TcPco2. We conclude that periwound cutaneous perfusion is the critical physiological determinant of diabetic ulcer healing, indicating a 39-fold increased risk of early healing failure when the average periwound TcPo2 is less than 20 mmHg.
Limb- or life-threatening complications in patients with diabetes can be prevented with an integrated, multidisciplinary approach. Most patients seen in clinical practice are in the early stages of the disease process. Glycemic control retards the progression of neuropathy, which is the most important risk factor for ulceration. Early detection of the loss of protective sensation and implementation of strategies to prevent ulceration will reduce the rates of limb-threatening complications. Clinicians should routinely examine the feet of diabetic patients. Education in foot care, proper footwear, and close follow-up are required to prevent or promptly detect neuropathic injury. If ulceration occurs, removal of pressure from the site of the ulcer and careful management of the wound will allow healing in most cases. The failure to heal despite these measures should prompt a search for associated arterial insufficiency. If infection is present, appropriate antimicrobial therapy combined with immediate surgical intervention, including revascularization when necessary, will increase the chances of saving the limb. With this comprehensive approach, it is possible to achieve the goal of a 40 percent decrease in amputation rates among diabetic patients by the year 2000.
The success of venous leg ulcer treatment can be evaluated by various parameters like wound area reduction in square millimeters, percent reduction of ulcer size, reduction of wound radius, and time of wound closure. Which one is the most reliable parameter if different treatment forms (i.e. various ointments) are to be compared? The best parameter for the evaluation of the speed at which chronic ulcers heal was the daily wound radius reduction, calculated from the wound area by planimetry. Under a standardized treatment (polyvidoniodine ointment, pressure bandaging) the daily ulcer radius fell on the average by 0.24 mm indicating a continuous growth of skin tissue from the wound circumference. Conversely, the daily wound area reduction in mm2 or in percent was difficult to interpret due to the parabolic shape of the area reduction curve. Here the following characteristics were noted: Large wounds displayed a relatively quick reduction of the wound area and at the same time a slow percental wound diminution. Small wounds, on the other hand, displayed a relatively slow reduction of the wound area and at the same time a relatively quick percent wound diminution. The period of time during which a wound became completely closed was equally unsuited for the assessment of therapeutic success because large ulcers healed slower than smaller ones. We conclude from these results that reduction of the wound radius should be used as the most reliable parameter for the evaluation of venous leg ulcer healing.
The severity of arterial ischemia is a major variable affecting healing of extremity wounds. By relating risk of failure to severity of ischemia, the probability of wound healing may be stratified along with assessment of general medical risks. Transcutaneous oxygen tension (TcPO2) arterial segmental pressure (ASP), and arterial segmental indices (ASI) were obtained in 204 ischemic lower extremity sites; 63% of the sites were in patients with diabetes mellitus (DM), 11% in patients with chronic renal failure (CRF), and 37% in patients with neither DM nor CRF (ND). Wounds included 126 amputations and 78 gangrenous ulcerations of the foot or toes. Healing (n = 112) was defined as complete wound closure, without regard to the time required. Failure (n = 92) was defined by the requirement for either arterial reconstruction (n = 45) or proximal amputation (n = 47). Stepwise multiple regression analysis was used to assess the relative contribution of each measurement and to predict the probability of healing; TcP02 was superior to ASP and ASI in all categories. TcP02 was the only test meeting the P < 0.05 entry criteria modeled by the regression. An accuracy of 83% was achieved. However, when each test was evaluated by univariate analysis, ASP and ASI did meet the criteria for the ND group. However, the accuracy was 68 and 72%, respectively. Predictive accuracy of TcP02 was unaffected by DM or CRF. ASP and ASI were satisfactory in the ND group, although of slightly reduced accuracy. ASP and ASI were misleading and inaccurate in DM and CRF. Thus, of the noninvasive tests, TcP02 alone is sufficient for objective risk stratification of arterial ischemia in the lower extremity.
The purpose of this study is to identify in-hospital mortality of diabetic amputees and the disposition of survivors in The Netherlands in 1991 and 1992. A database including all hospitalizations in The Netherlands was used. Amputees who died while in the hospital were analysed separately. Survivors were categorized according to different types of discharge: home, nursing home, rehabilitation facility, and other health care facilities. Overall 9.0% of diabetic amputees died while in hospital. The age-adjusted mortality incidence for the diabetic population was 36.3 per 1000 diabetic amputees (95% CI: 18.7-53.9) and 28.2 per 1,000 non-diabetic amputees (95% CI: 20.5-35.9). Non-diabetic amputees with PVD has proportionally more mortality than diabetic amputees with PVD (P < 0.01), diabetic amputees without PVD (P < 0.01), and non-diabetic amputees without PVD (P < 0.001). Using Cox regression analysis age (B(age) = 0.023, RR = 1.024) and the occurrence of multiple amputations during the hospitalization (Bmultiple = 0.325, RR = 1.383) were significant negative predictors for survival. As age and level of amputation increased, more diabetic and non-diabetic amputees were discharged to facilities other than home (P < 0.001).
There has been a broad interest in the use of growth factors to treat patients with chronic nonischemic diabetic ulcers.
One hundred eighteen patients were studied in a randomized, prospective, double-blind, multicenter trial comparing treatment with topically applied recombinant human platelet-derived growth factor (rhPDGF) or placebo (vehicle) and were treated until completely healed or to 20 weeks. All patients had aggressive sharp debridement of their ulcers before randomization and repeat debridement of callus and necrotic tissue as needed. The influence of debridement was evaluated by reviewing the records of the office visits where debridement was performed.
Forty-eight percent of patients treated with rhPDGF healed compared with 25 percent of patients who received placebo (p = 0.01). The mean percentage of office visits where debridement was performed was comparable for the two treatment groups: 46.8 percent (rhPDGF) and 48.0 percent (placebo). In general, a lower rate of healing was observed in those centers that performed less frequent debridement. The improved response rate observed with more frequent debridement was independent of the treatment group. However, for any given center, the percentage of patients who healed was greater with rhPDGF than placebo.
Wound debridement is a vital adjunct in the care of patients with chronic diabetic foot ulcers.
The objective of this study was to evaluate the relationship between foot ulceration and short-term mortality in veterans of the American military services with diabetes mellitus. A total of 725 diabetic subjects participated in a prospective study of risk factors for lower extremity complications between 1990 and 1994. Mean follow-up was 691.8 days (+/-SD 339.9, range 28-1436 days). Subjects who died during follow-up (n = 72) had a similar mean duration of diabetes to those who survived (12.6 years vs 11.2), but their mean age was greater (65.9 years vs 63.2, p = 0.026). The relative risk (RR) of death was 2.39 (95% confidence interval (CI) 1.13 to 4.58) in the subjects who developed foot ulcer (n = 88) compared to those who did not. The risk of death for those with foot ulcer was 12.1 per 100 person-years of follow-up compared to 5.1 in those without foot ulcer. Cox regression analysis demonstrated a greater than two-fold increased risk of death in ulcerated subjects after adjustment for age; diabetes type, duration, and treatment; glycosylated hemoglobin level; history of lower extremity amputation; and cumulative pack years smoked. Higher ankle-arm index was significantly related to lower mortality risk, independent of foot ulcer occurrence. We conclude that foot ulcer and lower extremity vascular disease are related to a higher risk of death in diabetic subjects. The reasons for this excess mortality require further investigation.
The aim of this study is to compare the effectiveness of total contact casts based on wound location in groups of patients with diabetes mellitus with neuropathic ulcerations under the forefoot and patients with midfoot ulcerations associated with acute Charcot's arthropathy. Twenty-five consecutive diabetic patients with Meggitt-Wagner grade I neuropathic foot ulceration (NU) and 22 consecutive diabetic patients with neuropathic ulceration and acute Charcot's arthropathy (CU) were selected for study. Larger wounds took longer to heal in both the CU (p < 0.0001) and NU groups (p < 0.0001). Duration of ulcer prior to treatment also was significantly associated with increased healing time in both groups (p = 0.008 NU, p = 0.03 CU). The CU group had larger wounds (10.3 +/- 4.6 vs 7.7 +/- 4.0 cm2, p = 0.04) but took significantly less time to heal (28.4 +/- 13.0 vs 38.8 +/- 21.3 days, p = 0.04) than did subjects with neuropathic ulcerations only. The NU group had their ulcers present for a significantly longer period of time prior to contact casting (88.5 +/- 98.3 vs 17.7 +/- 12.9 days, p = 0.001). In this study, subjects with ulcerations secondary to acute Charcot fractures healed more rapidly than in previous reports with healing times of forefoot neuropathic ulcers similar to previous studies. Every patient's ulcer healed. There were no cast-related ulcerations, infections, or hospitalizations. Concerns regarding the safety of total contact casts to treat well-vascularized superficial forefoot and midfoot plantar wounds appear to be unfounded.
Foot ulceration and lower limb amputation are still common complications of diabetes. Diabetic peripheral neuropathy and peripheral vascular disease are the most important etiologic factors, but there is a complex interplay between these abnormalities and a number of other contributory factors, such as altered foot pressures, limited joint mobility, glycemic control, ethnic background, and cardiovascular parameters. Identification of patients at high risk of ulceration is nevertheless simple, and education of such patients can achieve a major reduction in amputation and ulceration rates.
Metabolic and nutritional aspects of wound healing are discussed in this article, as well as the effects of both acute and chronic hyperglycemia, hyperinsulinemia, end-organ complications of diabetes, and impaired nutritional status of wound healing. Specific recommendations regarding the perioperative management of patients with diabetes mellitus are set forth, and the importance of achieving tight glucose control and overall improved metabolic control are emphasized.
Wounds on the feet of diabetic patients are often labeled as "non-healing." This article discusses the basis for and the dangers of such a classification. The evidence suggests that if the foot has an adequate vascular supply and no significant infection, a plantar wound that does not heal is the result of poor treatment and/or poor compliance. Wounds that do not heal despite optimal treatment and compliance are extremely rare and need to be referred to the appropriate specialist for care.
In a diabetic foot, ulcers can lead directly to the loss of a limb, and they may be life threatening if the patient is not provided effective intervention directed at healing. This study reports on the healing times of diabetic neuropathic plantar ulcers in the presence of fixed deformities of the foot using the ambulatory method of total contact casting (TCC). In this study, 21 subjects with chronic diabetes mellitus, plantar ulcers, and fixed deformities of the foot were put in casts, and their progress was followed until the ulcers were completely healed. Results indicated that all of the ulcers healed. The average time to healing was 67 +/- 29 days. Ulcers located in the forefoot, midfoot, and rearfoot healed in an average of 35 +/- 12 days, 73 +/- 28 days, and 90 +/- 12 days, respectively. The location of the ulcer and the presence and location of a fixed deformity of the foot strongly correlated with and was predictive of healing time using TCC. The location of the ulcers and the location of the fixed deformities of the foot should always be considered by providers of rehabilitation who treat diabetic neuropathic foot ulcers using TCC.
Diabetic foot ulcers are a significant healthcare problem affecting more than 1 million patients at some point in their lifetime. Good ulcer care begins with thorough assessment of the ulcer, which includes determining whether the ulcer is infected and whether neuropathy or peripheral vascular disease is present. The principles of good wound care include use of proper footwear, non-weight-bearing limb support, use of appropriate antibiotics, debridement, aggressive revascularization, control of serum glucose levels, and careful monitoring of the ulcer. For refractory ulcers, new therapies, such as the use of exogenous recombinant growth factors, are being developed that may have a significant benefit in treating these ulcers and lowering the amputation rate.
Foot ulcerations and their sequelae remain a major source of morbidity for patients with diabetes mellitus. Often leading to infection, osteomyelitis, or gangrene, these lesions have consistently been ascertained as significant risk factors for subsequent lower extremity amputation. Hence education, appropriate foot care, and early intervention have assumed important roles in programs focused on amputation prevention. Multidisciplinary cooperation has been demonstrated as the most successful approach to the management and prevention of foot lesions in patients with diabetes. This article reviews the epidemiology, current understanding of the underlying pathophysiology, and treatment rationale for diabetic foot ulcerations. Such knowledge is essential in the overall management of these complicated patients and, when incorporated into daily practice, can significantly reduce the incidence and morbidity of foot disease in diabetes.
To compare the healing time of neuropathic plantar ulcers treated by total-contact casting (TCC) in diabetic, immunosuppressed patients after organ transplantation with the healing time of plantar ulcers in control nonimmunosuppressed patients.
A case-control design with the control group matched for age, race, sex, body dimensions (height, weight, and body mass index), presence of sensory neuropathy, foot deformity presence and location, and pedal ulcer area and depth.
An outpatient physical therapy clinic in a regional tertiary-care hospital and academic medical center.
Nine patients with chronic diabetes mellitus and a previous organ transplantation who were currently receiving lifelong immunosuppressive drug therapy were treated for a neuropathic plantar ulcer by means of TCC. Fourteen group-matched control subjects with diabetes mellitus and a plantar ulcer but who had never had an organ transplantation and were not taking immunosuppressive agents were also studied.
TCC with partial weight-bearing using an assistive device until ulcers healed.
Healing time was defined as the number of days in the total-contact cast until the skin completely closed.
All diabetic foot ulcers healed with casting. Immunosuppressed/transplanted patients healed in a mean time of 111 +/- 25 days; ulcers of control subjects healed in 47 +/- 18 days (p < .05). All patients returned to ambulation using prescribed therapeutic footwear. None of the patients required a lower extremity amputation throughout the follow-up period.
TCC is a highly effective and rapid method of healing neuropathic pedal ulcers in diabetic immunosuppressed/transplantation patients, although it may take several weeks longer than it would for patients who were not immunocompromised.
To assess the value of treatments for foot ulcers in patients with Type 2 diabetes mellitus.
A systematic review of interventions to treat diabetic foot ulcers.
The evidence base for treating infections and dressing wounds is poor. A number of new and potentially promising treatments are being developed but currently available studies are often small, inadequately powered and use different methods and outcomes.
Given the prevalence, morbidity and healthcare costs of diabetic foot disease, it is surprising that available trials provide inadequate evidence to improve upon current empirically based treatment approaches. Substantial effort and resources should be deployed in order to investigate both new and existing treatments in a co-ordinated, systematic and consistent manner, so that a proper evidence base can be established for this important disease area.
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Our objectives were to 1) estimate the prevalence of diabetes and diabetic lower-extremity ulcers in the Medicare population, 2) characterize Medicare population-specific costs for lower-extremity ulcer episodes, and 3) evaluate potential cost savings associated with better healing of lower-extremity ulcers.
Prevalence and costs of diabetic lower-extremity ulcers were obtained by an analysis of Medicare claims data from 1995 and 1996 Standard Analytic Files (5% sample).
Medicare expenditures for lower-extremity ulcer patients were on average 3 times higher than those for Medicare patients in general (5,226). Lower-extremity ulcer-related spending accounted for 24% of total spending for lower-extremity ulcer patients. Most of the ulcer-related costs accrued on the inpatient side (73.7%); proportionately smaller amounts went to physicians and nursing home facilities. To determine the potential effect of better diabetic ulcer management, a model was created that estimated the impact on costs with improved healing rates. Improving the 20-week healing rate from 31 to 40% would save Medicare 1.5 billion in 1995. Any wound care intervention that could prevent even a small percentage of wounds from progressing to the stage at which inpatient care is required may have a favorable cost effect on the Medicare system.
The outcome of foot ulcers is affected by wound depth, infection, ischaemia and glycaemic control. The aim of this study was to determine the effects of ulcer size, site, patient's age, sex and type and duration of diabetes on the outcome of diabetic foot ulcers.
Diabetic patients with new foot ulcers presenting during a 12-month period had demographics and ulcer characteristics recorded at presentation. Ulcers were followed-up until an outcome was noted.
One hundred and ninety-four patients (77% males) with a mean (+/- SD) age and duration of diabetes of 56.6 +/- 12.6 and 15.4 +/- 9.9 years, respectively, were included in the study. The majority of ulcers were neuropathic (67.0%) and present on the forefoot (77.8%) with a median (interquartile range) area of 1.5 (0.6-4.0) cm2. Amputations were performed for 15% of ulcers; 65% healed; 16% remained unhealed and 4% of patients died. The median (95% confidence interval) time to healing was 10 (8.8-11.6) weeks. Ulcer area at presentation was greater in the amputation group compared to healed ulcers (3.9 vs. 1.2 cm2, P < 0.0001). Ulcer area correlated with healing time (rs = 0.27, P < 0.0001) and predicted healing (P = 0.04). Patient's age, sex, duration/type of diabetes, and ulcer site had no effect on outcome.
Ulcer area, a measure of ulcer size, predicts the outcome of foot ulcers. Its inclusion into a diabetic wound classification system will make that system a better predictor of outcome.
Healing rate measurement can predict complete wound healing rate in chronic dia-betic foot ulceration
- H Pham
- V Falanga
- M L Sabolonski
- A Veves
Pham, H., Falanga, V., Sabolonski, M. L., & Veves, A. (2000). Healing rate measurement can predict complete wound healing rate in chronic dia-betic foot ulceration. Diabetologia, 43.
Healing rate measurement can predict complete wound healing rate in chronic diabetic foot ulceration
- Pham