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Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot. Between June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit. Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event. Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot. A total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263). We recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence. ClinicalTrials.gov NCT02995863.

Leprosy is a curable disease, treated by multidrug therapy. However, patients are often left with neuropathic damage leading to lifelong vulnerability to ulcers. Quantifying the value of interventions to improve ulcer healing is challenging as data on the health impact of plantar ulcers are scarce, especially in low- and middle-income countries. We aim to quantify the impact of plantar ulcers on patients' health-related quality of life (HRQoL) using methods which can inform decisions about the effectiveness and cost-effectiveness of alternative forms of management. Generic HRQoL data were collected using the EuroQol (EQ)-5D-3L questionnaire in a randomised control trial in Nepal, treating plantar ulcers with leukocyte and platelet-rich fibrin or usual care. The trial followed 130 patients resulting in 600 observations. EQ-5D data were converted into a single 'utility' score by weighting the instrument's different dimensions using the preferences of the Sri Lankan population. Utility data were analysed using general estimating equation regressions. The impact of an ulcer on HRQoL was estimated whilst controlling for clinical and demographic covariables. Estimated mean utility (standard error) for the sample across all time points was 0.52 (0.02) for patients with an ulcer and 0.64 (0.01) with a healed ulcer. Controlling for clinical and demographic covariates, we estimate that the presence of an ulcer leads to a 0.12 (0.02) decrement in HRQoL compared with a healed ulcer. Based on the levels of health they report and the values of the general public, patients with a history of leprosy are at risk of significant HRQoL burden from neuropathic plantar ulcers. Quantifying this health impact provides important evidence to assess the effectiveness and cost-effectiveness of leprosy ulcer interventions and ensures that interventions for leprosy ulcers can be appropriately considered for funding under Universal Health Coverage against other potential uses of the same money.

Management of diabetic foot ulcers (DFUs) is a great challenge for clinicians. Although the oxygen-ozone treatment improves the diabetic outcome, there are few clinical trials to verify the efficacy and illuminate the underlying mechanisms of oxygen-ozone treatment on DFUs. In the present study, a total of 50 type 2 diabetic patients complicated with DFUs, Wagner stage 2~4, were randomized into control group treated by standard therapy only and ozone group treated by standard therapy plus oxygen-ozone treatment. The therapeutic effects were graded into 4 levels from grade 0 (no change) to grade 3 (wound healing). The wound sizes were measured at baseline and day 20, respectively. Tissue biopsies were performed at baseline and day 11. The expressions of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF) proteins in the pathologic specimens were determined by immunohistochemical examinations. The effective rate of ozone group was significantly higher than that of control group (92% versus 64%, P<0.05). The wound size reduction was significantly more in ozone group than in control group (P<0.001). After treatment, the expressions of VEGF, TGF-β, and PDGF proteins at day 11 were significantly higher in ozone group than in control group. Ozone therapy promotes the wound healing of DFUs via potential induction of VEGF, TGF-β, and PDGF at early stage of the treatment. (Clinical trial registry number is ChiCTR-TRC-14004415).

Weight-bearing exercise has been contraindicated among people with diabetic peripheral neuropathy (DM+PN). However, recent cohort studies have suggested that daily weight-bearing activity is associated with lower risk for foot ulceration. The objective of this study was to determine the effect of a lower-extremity exercise and walking intervention program on weight-bearing activity and foot ulcer incidence in people with DM+PN. This was an observer-blinded, 12-month randomized controlled trial. The settings were physical therapy offices in part 1 of the intervention and the community in part 2 of the intervention. The participants were 79 individuals with DM+PN who were randomly assigned either to a control group (n=38) or an intervention group (n=41) group. Intervention components included leg strengthening and balance exercises; a graduated, self-monitored walking program (part 1); and motivational telephone calls every 2 weeks (part 2). Both groups received diabetic foot care education, regular foot care, and 8 sessions with a physical therapist. Total and exercise bout-related daily steps at baseline and at 3, 6, and 12 months were measured by accelerometers. Foot lesions/ulcers were photographed and classified by an independent panel of dermatologists. Use of adequate footwear was monitored. At 6 months, bout-related daily steps increased 14% from baseline in the intervention group and decreased 6% from baseline in the control group. Although the groups did not differ statistically in the change in total daily steps, at 12 months steps had decreased by 13% in the control group. Foot ulcer rates did not differ significantly between groups. Promoting weight-bearing activity did not lead to significant increases in foot ulcers. Weight-bearing activity can be considered following adequate assessment and counseling of patients with DM+PN.

Chronic neuropathic ulcers remain a debilitating complication of leprosy, with limited evidence for effective treatments. Honey has been recommended to promote wound healing in other chronic ulcers. However, its efficacy in ulcer healing has not been rigorously evaluated. This dual-centre, prospective, single-blinded, randomised controlled trial compared raw honey dressings (n = 65) versus standard saline dressings (n = 65) for leprosy-associated foot ulcers in Nigeria. Participants with ulcers (2-20 cm2, ≥ 6 weeks duration) were randomised 1:1, stratified by ulcer size. Primary outcomes were complete healing by 84 days and healing rate, assessed through blinded digital planimetry. Secondary outcomes included ulcer recurrence and/or new ulcer development at 6 months. A total of 130 participants were randomised in the study. Complete healing occurred in 29.2% of honey-treated ulcers versus 24.6% with saline (adjusted HR 1.26, 95% CI 0.64-2.47). At 6 months, recurrence rates were similar (honey 13.5% vs saline 10.2%). The honey group showed a non-significant trend toward faster healing (p = 0.076). No treatment-related adverse events occurred. While honey dressings showed a modest advantage in healing rate, the difference was not statistically significant. The results suggest honey may be a safe, culturally acceptable option in resource-limited settings. This study provides high-quality data for inclusion in future systematic reviews. ISRCTN10093277. Registered on 22 December 2021.

Background Lower extremity amputation (LEA) is a potential sequelae of diabetic foot ulceration (DFU) and is associated with huge morbidly and mortality. Low and middle income countries are currently at the greatest risk of diabetes-related complications and deaths. We sought to identify demographic, clinical and laboratory variables that significantly predict LEA in patients hospitalized for DFU. Methods The Multi-center Evaluation of Diabetic Foot Ulcer in Nigeria (MEDFUN) was an observational study conducted between March 2016 and April 2017 in six tertiary healthcare institutions. We prospectively followed 336 diabetic patients hospitalized for DFU and managed by a multidisciplinary team until discharge or death. Demographic and diabetes-related information and ulcer characteristics were documented. Patients were evaluated for neuropathy, peripheral arterial disease (PAD) and medical co-morbidities while relevant laboratory and imaging tests were performed. The study end-points were ulcer healing, LEA, duration of hospitalization and mortality. Here we present data on amputation. Results One hundred and nineteen subjects (35.4%) underwent LEA during the follow-up period. Univariate predictors of LEA were ulcer duration more than 1 month prior to hospitalization ( P  <  0.001), PAD ( P  <  0.001), Wagner grade ≥ 4 ( P  <  0.001), wound infection (P 0.041), Proteinuria (P 0.021), leucocytosis (P 0.001) and osteomyelitis ( P  <  0.001). On multivariate regression, only three variables emerged as significant independent predictors of LEA and these include: ulcer duration more than 1 month (O.R. 10.3, 95% C.I. 4.055–26.132), PAD (O.R. 2.8, 95% C.I. 1.520–5.110) and presence of osteomyelitis (O.R. 5.6, 95% C.I. 2.930–10.776). Age, gender, diabetes type and duration, neuropathy, glycemic control and anemia did not predict LEA in the studied population. Conclusion We identified duration of ulcer greater than 1 month, PAD, Wagner grade 4 or higher, proteinuria, leucocytosis, wound infection and osteomyelitis as the significant predictors of LEA in patients hospitalized for DFU. Prompt attention to these risk factors may reduce amputation rate among these patients.

OBJECTIVE:--The purpose of this study was to evaluate the effectiveness of a temperature monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications. RESEARCH DESIGN AND METHODS--In this physician-blinded, randomized, 15-month, multicenter trial, 173 subjects with a previous history of diabetic foot ulceration were assigned to standard therapy, structured foot examination, or enhanced therapy groups. Each group received therapeutic footwear, diabetic foot education, and regular foot care. Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook. If standard therapy or structured foot examinations identified any foot abnormalities, subjects were instructed to contact the study nurse immediately. Subjects in the enhanced therapy group used an infrared skin thermometer to measure temperatures on six foot sites each day. Temperature differences >4°F (>2.2°C) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized. RESULTS:--The enhanced therapy group had fewer foot ulcers than the standard therapy and structured foot examination groups (enhanced therapy 8.5 vs. standard therapy 29.3%, P = 0.0046 and enhanced therapy vs. structured foot examination 30.4%, P = 0.0029). Patients in the standard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group. CONCLUSIONS:--Infrared temperature home monitoring, in serving as an \"early warning sign,\" appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations.

Aims/hypothesisApproximately 25% of people with type 2 diabetes experience a foot ulcer and their risk of amputation is 10–20 times higher than that of people without type 2 diabetes. Prognostic models can aid in targeted monitoring but an overview of their performance is lacking. This study aimed to systematically review prognostic models for the risk of foot ulcer or amputation and quantify their predictive performance in an independent cohort.MethodsA systematic review identified studies developing prognostic models for foot ulcer or amputation over minimal 1 year follow-up applicable to people with type 2 diabetes. After data extraction and risk of bias assessment (both in duplicate), selected models were externally validated in a prospective cohort with a 5 year follow-up in terms of discrimination (C statistics) and calibration (calibration plots).ResultsWe identified 21 studies with 34 models predicting polyneuropathy, foot ulcer or amputation. Eleven models were validated in 7624 participants, of whom 485 developed an ulcer and 70 underwent amputation. The models for foot ulcer showed C statistics (95% CI) ranging from 0.54 (0.54, 0.54) to 0.81 (0.75, 0.86) and models for amputation showed C statistics (95% CI) ranging from 0.63 (0.55, 0.71) to 0.86 (0.78, 0.94). Most models underestimated the ulcer or amputation risk in the highest risk quintiles. Three models performed well to predict a combined endpoint of amputation and foot ulcer (C statistics >0.75).Conclusions/interpretationThirty-four prognostic models for the risk of foot ulcer or amputation were identified. Although the performance of the models varied considerably, three models performed well to predict foot ulcer or amputation and may be applicable to clinical practice.

OBJECTIVE:--We studied the relationships of diabetic ulcer wound fluid matrix metalloproteinases (MMPs), tissue inhibitors of metalloproteinases (TIMPs), and transforming growth factor-ss1 (TGF-ss1) with wound healing rate. RESEARCH DESIGN AND METHODS--The ulcers were cleansed to remove exudates, and wound fluids were collected for analysis of MMP-2 and -9, TIMP-1, and TGF-ss1. RESULTS:--At presentation, MMP-9 and the MMP-9-to-TIMP-1 ratio correlated inversely with the wound healing rate at 28 days (P < 0.001). MMP-9 and the MMP-9-to-TIMP-1 ratio were lower in the 23 patients who achieved complete healing at 12 weeks versus the 39 who did not. The pro-MMP-9 concentration was predictive of healing within 12 weeks. Addition of cutoffs for TIMP-1 (>480 pg/ml) and TGF-ss (>115 pg/ml) further improved its predictive power (area under the curve 0.94). CONCLUSIONS:--These findings suggest that a milieu with high MMP-9 may be indicative of inflammation and poor wound healing. Measurements of MMP-9, TIMP-1, and TGF-ss in wound fluid may help to identify ulcers at risk of poor healing.

Aims/hypothesis Outcome data on individuals with diabetic foot ulcers are scarce, especially in those with peripheral arterial disease (PAD). We therefore examined the clinical characteristics that best predict poor outcome in a large population of diabetic foot ulcer patients and examined whether such predictors differ between patients with and without PAD. Methods Analyses were conducted within the EURODIALE Study, a prospective cohort study of 1,088 diabetic foot ulcer patients across 14 centres in Europe. Multiple logistic regression modelling was used to identify independent predictors of outcome (i.e. non-healing of the foot ulcer). Results After 1 year of follow-up, 23% of the patients had not healed. Independent baseline predictors of non-healing in the whole study population were older age, male sex, heart failure, the inability to stand or walk without help, end-stage renal disease, larger ulcer size, peripheral neuropathy and PAD. When analyses were performed according to PAD status, infection emerged as a specific predictor of non-healing in PAD patients only. Conclusions/interpretation Predictors of healing differ between patients with and without PAD, suggesting that diabetic foot ulcers with or without concomitant PAD should be defined as two separate disease states. The observed negative impact of infection on healing that was confined to patients with PAD needs further investigation.