A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers
- Resource Type
- Article
- Authors
- Serena, Thomas E; Yaakov, Raphael; Moore, Sarah; Cole, Windy; Coe, Stacey; Snyder, Rob; Patel, Keyur; Doner, Bryan; Kasper, Maria A; Hamil, Rachel; Wendling, Santina; Sabolinski, Michael L
- Source
- Journal of Comparative Effectiveness Research; November 2019, Vol. 9 Issue: 1 p23-34, 12p
- Subject
- Language
- ISSN
- 20426305; 20426313
Aim:Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods:A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results:Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16–2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion:HSAM increased frequency and probability of wound closure in DFUs versus SOC.