The role of chloramines in treatment of diabetic foot ulcers: an exploratory multicentre randomised controlled trial

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9% p=0.008; mPP: 59.5% versus 35.6% p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.

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Advances in Dermoepidermal Skin Substitutes for Diabetic Foot Ulcers

Current Vascular Pharmacology ◽

10.2174/1570161117666190408170144 ◽

2020 ◽

Vol 18 (2) ◽

pp. 182-192 ◽

Cited By ~ 1

Author(s):

Francisco Javier Álvaro-Afonso ◽

Yolanda García-Álvarez ◽

Jose Luis Lázaro-Martínez ◽

Despoina Kakagia ◽

Nikolaos Papanas

Keyword(s):

Diabetic Foot ◽

Standard Care ◽

Wound Closure ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Retrospective Evaluation ◽

Skin Substitutes ◽

Clinical Reality ◽

Randomised Controlled

Diabetic foot ulcers (DFUs) are one of the major complications of diabetes, representing a leading cause of hospitalisation and non-traumatic lower limb amputations. Multidisciplinary management, patient education, glucose control, debridement, off-loading, infection control, and adequate perfusion are the mainstays of standard care. Despite all these, at least 30% of DFUs fail to heal within 20 weeks. Therefore, dermoepidermal skin substitutes (DSS) have been used as a new therapeutic adjunct for DFUs. This brief review outlines the recent advances in DSS for the treatment of DFUs. PubMed and Cochrane databases were systematically searched in May to July 2018 for systematic reviews published after 2013 and for randomised controlled trials (RCTs). A retrospective evaluation of 28 RCTs was performed. Rates of complete wound closure and time to healing were examined for 17 commonly available DSS. Healing rates after 12 weeks and time to complete closure in DFUs are heterogeneous among the 28 RCT. The best healing rates at 12 weeks were accomplished with dermal cellular substitutes (Epifix®, 100% and Amnioband®, 85%) and with dermal acellular substitutes (Allopatch®, 80% and Hyalograft®, 78.8%). Based on these studies, DSS used in conjunction with standard care appear to improve the healing rates of DFUs, as compared with standard care alone. Nonetheless, new studies with more homogeneous samples are needed to ascertain the role of ulcer size, duration, depth and/or type in the efficacy of DSS. Moreover, future RCTs should include patients with severe comorbidities, in order to be more representative of clinical reality.

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