A Prospective, Multicenter Randomized Controlled Trial of dehydrated Amnion Chorion Membrane Compared to Standard of Care for the Management of Diabetic Foot Ulcers

Introduction: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This randomized controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM)(a) and standard of care (SOC) in complex DFUs in a challenging patient population.Methods:218 subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated to one of two treatment groups: 1) dACM plus SOC; (n=109), or 2) SOC alone; (n=109). The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier (KM) analysis was used to determine median time to complete wound closure (CWC).Results:A Cox analysis showed the estimated frequency of wound closure for dACM was statistically superior to SOC at week 4 (12 vs. 8%), 6 (22 vs. 11%), 8 (31 vs. 21%), 10 (42 vs. 27%), and 12 (50% vs. 35%); p=0.04. The computed Hazard Ratio [HR=1.48 (0.95, 2.29)] showed a 48% greater probability of wound closure in favor of the dACM. Median time to wound closure for dACM- treated ulcers was 84 days compared to “not achieved” in the SOC group (i.e., ≥ 50% of SOC- treated DFUs failed to heal by week 12); p = 0.04.IDiscussion: n a well powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared to SOC alone. dACM demonstrated beneficial effects in recalcitrant DFUs in a complex patient population. References: