Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi‐centre clinical trial in 80 patients

Abstract

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs. After a 2-week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA-treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA- treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

“…Then, detailed evaluation of full texts resulted in the removal of 34 articles for the following reasons: were reviews (n = 23); were not RCTs (n = 7); was a duplicate study (n = 1) 26 ; ST was not used as control treatment (n = 3) 27‐29 . Finally, nine studies were eligible for this meta‐analysis 18,30‐37 . The study 34 published by Zelen et al in 2016 was an extension of their previous study 31 published in 2015.…”

“…All studies reported random allocation of patients to the intervention and control groups, although the method of random sequence generation was not well described in one study 28 . Only four studies 31,34,35,37 reported allocation concealment. Participants and personnel in most studies 18,30,31,33,34,36,37 were aware of group assignment while outcome assessors were blinded to group assignment in six studies 30,31,34‐37 .…”

“…Only four studies 31,34,35,37 reported allocation concealment. Participants and personnel in most studies 18,30,31,33,34,36,37 were aware of group assignment while outcome assessors were blinded to group assignment in six studies 30,31,34‐37 . For attrition bias and reporting bias, all studies were considered to have a low risk.…”

Potential of Allogeneic Adipose-Derived Stem Cell–Hydrogel Complex for Treating Diabetic Foot Ulcers

“…This is the key highlight of our study. In this study, the follow-up duration was 12 weeks because many previous similar clinical trials for diabetic wound healing also used 12 weeks for the follow-up duration (13,14,18,(32)(33)(34)(35). For precise assessment of the efficacy of the allogeneic ASC treatment, we excluded external confounding factors that could have affected the treatment such as vascular insufficiency and infection.…”

Benefits of cryopreserved human amniotic membranes in association with conventional treatments in the management of full‐thickness burns

“…More recently, a hypothermically stored amniotic membrane (at +4°C) was proposed to be used in an environment of chronic wound . Also dehydrated amniotic membrane is already used in diabetic foot ulcers, venous leg ulcers, and several chronic wounds. It was shown to be equivalent to cryopreserved ones in terms of (a) growth factors composition, (b) induction of fibroblast and keratinocyte proliferation, and (c) angiogenesis induction .…”