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Wounds. 2017 May;29(5):125-132.

The Comparative Effectiveness of a Human Fibroblast Dermal Substitute versus a Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Diabetic Foot Ulcers in a Real-world Setting.



Impaired wound healing is associated with serious complications in patients with diabetes. Diabetic foot ulcers (DFUs) can lead to costly complications and an increased mortality rate. Standard treatments for DFUs often need to be augmented with adjunctive therapies designed to stimulate healing in recalcitrant wounds.


This analysis was conducted to evaluate the comparative effectiveness of a human broblast-derived dermal substitute (HFDS) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of DFUs.


Using a wound care-specic electronic health record database, real-world outcomes from 122 patients with 122 DFUs receiving treatment in 2014 in 72 wound care facilities across the United States were evaluated. Key criteria for entry into the analysis included ulcer size ≥ 1 cm2 to < 25 cm2, ulcer duration ≤ 1 year, and ulcer area reduction ≤ 20% in the 14 days prior to the rst treatment. Key exclusion criteria included lack of follow-up visits and lack of baseline wound measurements. The frequency of wound closure by weeks 12 and 24, median time to wound closure, hazard ratio with 95% con dence interval, and P value were estimated from a Cox model with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, and wound location.


The results show the incidence of wound closure for HFDS compared with dHACM was signicantly improved by weeks 12 (55% vs. 32%) and 24 (76% vs. 50%). The HFDS treatment signi cantly increased the probability of wound closure by 107%, with a median time to closure of 7.4 weeks (38%) less than that of dHACM treatment (P = .02).

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