A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers


Thomas E Serena 1, Raphael Yaakov 2, Sarah Moore 2, Windy Cole 3, Stacey Coe 3, Rob Snyder 4, Keyur Patel 5, Bryan Doner 5, Maria A Kasper 6, Rachel Hamil 2, Santina Wendling 7, Michael L Sabolinski

Main idea: hypothermically stored amniotic membrane increased frequency and probability of wound closure in diabetic foot ulcers versus standard of care.


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 at weeks 12, and 16. The probability of wound closure increased by 75%. HSAM showed >60% reductions in area and depth versus SOC.


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