OBJECTIVES: 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) and standard of care (SOC) in Wagner grade 1 and 2 DFUs.

METHODS: 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 three dimensional digital planimetry, and wound closure efficacy endpoints were evaluated.

RESULTS: The treatment groups had no significant differences in baseline demographics and ulcer characteristics. 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 at week 4 (11 vs. 3%), 8 (36 vs. 23%), 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 unadjusted for covariates demonstrated that the median time to wound closure for HSAM-treated ulcers was 42% faster than SOC-treated ulcers (11 vs. 19 weeks). HSAM-treated DFUs showed significant improvements in wound measurements from baseline with a higher incidence of >60% reduction in area (82% vs. 58%), depth (65% vs. 39%), and >75% reduction in volume (81 vs. 58%).

CONCLUSIONS: 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, improving wound closure, and providing cost-effective care in non-healing DFUs. Evidence showed that HSAM increased the frequency and decreased the time to wound closure. HSAM also showed greater reductions in ulcer area, depth, and volume.