Publications library Research article
J Comp Eff Res · 2020
Serena, T.E., Yaakov, R., Moore, S., Cole, W., Coe, S., Snyder, R., Patel, K., Doner, B., Kasper, M.A., Hamil, R., Wendling, S., & Sabolinski, M.L.
Journal of Comparative Effectiveness Research (Future Medicine)
This multicenter randomized controlled trial at 14 US centers compared a hypothermically stored amniotic membrane (HSAM) plus standard care with standard care alone (debridement, dressings and total contact casting) in 76 patients with diabetic foot ulcers that had not responded to standard care. Wound closure, the primary endpoint, was significantly more frequent with HSAM at 12 weeks (55 vs 29%; p = 0.02) and 16 weeks (58 vs 29%; p = 0.01), and more HSAM-treated ulcers reached a greater than 60% reduction in area (82 vs 58%; p = 0.02). The trial was open label, closure was defined from digital measurements as an ulcer area between 0 and 0.1 cm2, and the study was funded by Organogenesis, Inc.
Co-authored by SerenaGroup researchers.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
