Bridging the Wound Gap: Interim Results From Randomized Trials Evaluating Dehydrated Human Amnion-Intermediate Layer-Chorion Membrane for the Treatment of Non-healing Diabetic Foot Ulcers.

Introduction Patients with diabetes frequently develop diabetic foot ulcers, a significant clinical pathology that results in increased morbidity and mortality. Standard of care (SOC) treatment has been insufficient to prevent the poor outcomes associated with these wounds. This analysis aims to evaluate the supplementation of SOC with a human tissue allograft. Methods This evaluation is of two prospective, multicenter, randomized clinical studies (ELITE - ongoing and CAMPLIFE - terminated) comparing a dehydrated human amnion-intermediate layer-chorion membrane (dHAICM) tissue allograft (AmchoPlast®, Cellution Biologics, Inc., Roswell, GA, US) as a supplement to SOC (dHAICM + SOC) versus SOC alone. Eligible target ulcers must have been present for a minimum of four weeks with SOC treatment and not have reduced in size by more than 20% during the screening period. Participants were treated weekly for up to 10 weeks in the ELITE study and 12 weeks in the CAMPLIFE study. Results Across the ELITE and CAMPLIFE studies, 90 participants were screened, with 64 total participants remaining eligible at the randomization visit who subsequently were enrolled. Of those, a total of 53 participants were eligible for inclusion in this analysis, 29 of whom had completed the study per protocol as of the data cutoff time for this analysis. A total of 18 participants (34%) achieved complete wound closure of their ulcers. In the SOC alone group, four participants healed (17%) compared to 14 (50%) in the dHAICM + SOC group, a statistically significant difference in healing between the two groups (P = 0.019). Utilizing a non-pooled sample from the ELITE study was also statistically significant; 12 participants (71%) in the dHAICM + SOC group healed, compared to three participants (23%) in the SOC alone group (P = 0.0253). A reduction in wound area of 71% ± 18.2% was observed for the dHAICM + SOC group and 46% ± 16.9% for the SOC alone group; however, this reduction did not reach statistical significance (P = 0.0517). In the interim analysis of the data from the ELITE study, a wound area reduction of 78% ± 23.3% was achieved by the dHAICM + SOC vs. a 38% ± 20.1% reduction for SOC alone, a statistically significant difference between the two groups (P = 0.018). No statistically significant improvements in pain scores, Wound Quality of Life assessments, or Forgotten Wound Score assessments were observed in either the pooled sample or the ELITE only analysis. Discussion Both analyzed study populations showed better outcomes for wound closure and wound area reduction when SOC was supplemented with dHAICM, although wound area reduction only reached statistical significance for the ELITE interim analysis. Conclusions Supplementing SOC treatment for diabetic foot ulcers increases the likelihood of the ulcer healing completely and improves the reduction in wound area.