Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series.

Abstract

EPIFIX, a dehydrated human amnion/chorion membrane allograft, received regulatory approval as a medical device in 2021 by the Ministry of Health, Labour and Welfare following review by the Pharmaceuticals and Medical Devices Agency, for the treatment of refractory ulcers, including diabetic foot ulcers. Insurance reimbursement under the Japanese national health insurance system was approved in 2022. This study investigated the efficacy of EPIFIX for diabetic foot ulcers in Japan. This study incl