Hypothermically Stored Human Amniotic Membrane (HSAM) for the Management of Diabetic Foot Ulcers

Abstract Body: Objective: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. They are prone to infection and increase the risk of lower extremity amputation. The aim of this study was to evaluate the effectiveness of a fresh hypothermically stored human amniotic membrane (HSAM)(a) and standard of care (SOC) in Wagner grade 1 and 2 DFUs. Approach: A randomized controlled trial (RCT) was conducted in which 76 subjects were allocated to HSAM and SOC (n=38) or SOC alone (n=38). Ulcer measurements were obtained using digital planimetry, and efficacy endpoints were evaluated. Results: The treatment groups had no significant differences in baseline demographics and ulcer characteristics. The unadjusted frequency of wound closure for HSAM-treated ulcers was significantly greater than SOC by 12 weeks (55% vs. 29%; p=0.02) and 16 weeks (58% vs. 29%; p=0.01). A Cox regression analysis adjusting for multiple covariates including ulcer area and duration showed that the estimated frequency of wound closure for HSAM was superior (p=0.04) to SOC at week 12 (60% vs. 38%), and 16 (63% vs. 38%). The computed hazard ratio [HR=1.75 (1.16, 2.70)] indicated a 75% greater probability of wound closure in favor of the HSAM group. Kaplan-Meier analysis showed that the median time to wound closure for HSAM-treated ulcers was 42% faster than SOC-treated ulcers (11 vs. 19 weeks). HSAM demonstrated a higher incidence of >60% reduction in area (82% vs. 58%; p=0.02) and depth (65% vs. 39%; p=0.04). Innovation: HSAM is not dehydrated or cryopreserved; it preserves native tissue benefits and is available for a 42-day shelf life. HSAM holds promise for accelerating the healing process in chronic wounds. Conclusion: The study provides evidence that HSAM increased the frequency and decreased the time to wound closure. HSAM also showed greater reductions in ulcer area and depth. (a) HSAM; Affinity®, Organogenesis, Canton, MA