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Background: Cell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers. Method: This study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis® Omega3 Wound™ versus Group 2 treatment with standard of care. The primary objective is to test the hypothesis that a larger number of severe diabetic ulcers and amputation wounds, including those with moderate arterial disease, will heal in 16 weeks when treated with Kerecis® Omega3 Wound™ than with standard of care. Conclusion: This study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.

OBJECTIVE: Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. The aim of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) in the management of chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS: The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers (HODFU) study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air. Treatments were given in a multi-place hyperbaric chamber for 85-min daily (session duration 95 min), five days a week for eight weeks (40 treatment sessions). The study was performed in an ambulatory setting. RESULTS: Ninety-four patients with Wagner grade 2, 3, or 4 ulcers, which had been present for >3 months, were studied. In the intention-to-treat analysis, complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up: 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P = 0.03). In a sub-analysis of those patients completing >35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group (P = 0.009). The frequency of adverse events was low. CONCLUSIONS: The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes.

Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care group (SOC, collagen alginate dressing) at 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridements when needed and an offloading device. The primary endpoint was proportion of full‐thickness, non‐infected, non‐ischaemic wounds healed at 12 weeks, with secondary endpoints including percent area reduction (PAR) and changes in Semmes‐Weinstein monofilament testing. The result illustrated in the intent‐to‐treat analysis at 12 weeks showed that 70% (14/20) of the BBGFM‐treated DFUs healed compared with 25% (5/20) treated with SOC alone (adjusted P = .006). Mean PAR at 12 weeks was 79% in the BBGFM group compared with 37% in the SOC group (adjusted P = .027). Mean change in neuropathic score between baseline and up to 12 weeks of treatment was 2.0 in the BBGFM group compared with −0.6 in the SOC group where positive improvement in scores are better (adjusted P = .008). The mean number of BBGFM applications was 6.0. In conclusion, adding BBGFM to SOC significantly improved wound healing with no adverse events related to treatment compared with SOC alone.

Background The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. Methods/design This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years. Discussion VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. Trial registration Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529 .

Purpose This study aimed to evaluate the effectiveness of early mobilization program with nonweight-bearing braces in improving functional outcomes and clinical indicators after diabetic foot ulcer surgery. Methods We conducted a randomized trial involving patients with diabetic foot ulcers (DFUs) who underwent surgery at a tertiary university hospital. Participants were randomized to receive either early mobilization with nonweight-bearing braces or standard rehabilitation care. The primary outcome was the ability to walk a distance of three meters without human assistance upon hospital discharge. Secondary outcomes included activity of daily living (ADL), measured by the Barthel Index survey; reduction in lean body mass, assessed via thigh circumference on postoperative day 10 (POD 10); length of stay (LOS); and the incidence of postoperative complications such as deep venous thrombosis (DVT), pain, and wound dehiscence. Results A total of 46 patients were enrolled, with 23 assigned to the early mobilization program with nonweight-bearing braces (intervention group) and 23 to the standard rehabilitation care group (control group). The primary outcome was achieved in 16 patients (69.6%) in the intervention group and 6 patients (26.1%) in the control group [RD43.5%, 95%CI (17.5%,69.5%); P  = 0.003]. The intervention group demonstrated improved outcomes in ADL. Additionally, the intervention facilitated earlier discharge with a LOS of 12 days in the intervention group compared to 18 days in the control group. Conclusion An early postoperative mobilization program with nonweight-bearing brace is demonstrated to be feasible and effective in improving functional capacity in patients with diabetic foot ulcers undergoing surgery.

The purpose of this study is to investigate the predictive value of neutrophil‐to‐lymphocyte ratio (NLR), serum calcium, and serum albumin on the prognosis of patients with diabetic foot. A total of 156 patients who were treated in the Department of Burn and Plastic Surgery of Qilu Hospital of Shandong University from 1 January 2014 to 1 August 2020 were selected. All the patients were randomly divided into a healing group, minor amputation group, major amputation group, and death group according to their treatment outcomes. The levels of NLR, serum calcium and serum albumin in each group were examined and compared. The correlations between NLR, serum calcium, and serum albumin with the prognosis of diabetic foot were analysed to investigate their predictive effects on the prognosis of diabetic foot. The results of one‐way ANOVA showed that among the 4 groups of patients, the difference in NLR values between the healing group and the minor amputation group was slightly smaller, but they were significantly different from the major amputation group and the death group, respectively. There was no significant difference in serum calcium levels between the healing group and the minor amputation group, but the serum calcium levels of the major amputation group and the death group gradually decreased. The levels of NLR in the 4 groups gradually increased, while the albumin levels gradually decreased. Spearman's rank correlation test indicated that NLR was significantly related to the prognosis of patients with diabetic foot. The group with higher NLR had a worse prognosis in diabetic foot patients. Serum calcium and serum albumin were strongly correlated with the prognosis of patients with diabetic foot. The group with lower serum calcium and serum albumin values had a worse prognosis in diabetic foot patients. The areas under the receiver operator characteristic curve of NLR, serum calcium and serum albumin were 0.901, 0.803, and 0.816, respectively. NLR, serum calcium and serum albumin can be used as reliable indicators to predict the prognosis of diabetic foot. Preoperative diabetic foot patients with higher NLR values or lower serum calcium and serum albumin have a poorer prognosis.

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single‐blinded, multi‐centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub‐studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub‐studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non‐healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.

Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi‐weekly, in addition to standard of care. The hypothesis was that bi‐weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks, and secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life. In the intent‐to‐treat population, 77% (10/13) of DFUs treated with bi‐weekly application healed compared with 69% (9/13) treated with weekly application. The mean time to heal within 12 weeks in the bi‐weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi‐weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi‐weekly group was 3.9 compared with 6.2 in the weekly group. The results of this trial confirm our hypothesis that whether bi‐weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing. Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs.

Diabetic foot ulcers are often unresponsive to conventional therapy and are a leading cause of amputation. Animal studies have shown stem cells and growth factors can accelerate wound healing. Adipose‐derived stem cells are found in fat grafts and mixing them with platelet‐rich plasma (PRP) may improve graft survival. This study aimed to establish the histological changes when diabetic foot ulcers are treated with fat grafts and PRP. A three‐armed RCT was undertaken of 18 diabetic foot ulcer patients: fat grafting; fat grafting with PRP; and routine podiatry care. Biopsies were obtained at week 0, 1, and 4, and underwent quantitative histology/immunohistochemistry (H&E, CD31, and Ki67). Treatment with fat and PRP increased mean microvessel density at 1 week to 1645 (SD 96) microvessels/mm2 (+32%‐45% to other arms, P = .035). PRP appeared to increase vascularity surrounding fat grafts, and histology suggested PRP may enhance fat graft survival. There was no clinical difference between arms. This study demonstrates PRP with fat grafts increased neovascularisation and graft survival in diabetic foot ulcers. The histology was not, however, correlated with wound healing time. Future studies should consider using apoptosis markers and fluorescent labelling to ascertain if enhanced fat graft survival is due to proliferation or reduced apoptosis. Trial registration NCT03085550.

Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with ClinicalTrials.gov, number NCT00224796. More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0·040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0·005). The rate of granulation tissue formation, based on the time to 76–100% formation in the wound bed, was faster in the NPWT group than in controls (p=0·002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.