Clinical Evaluation of AMNIODERM+^® Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial

Abstract

Chronic wounds result from the body’s inability to heal, causing pain, pathogen entry, limited treatment options, and societal burden. Diabetic foot ulcers are particularly challenging, often leading to severe complications like leg amputation. A clinical study tested AMNIODERM+®, a new device with a lyophilized human amniotic membrane (HAM), on chronic diabetic foot ulcers. Participants had diabetic neuropathic or neuroischemic leg wounds (2–16 cm2) unhealed by 20% after six weeks of standard care. This study showed significant wound healing improvements with AMNIODERM+®. The median wound size reduction after 12 weeks was 95.5%, far exceeding the null hypothesis of 20% change. Additionally, 65% of patients achieved complete ulceration healing, surpassing the 50% efficacy requirement. The median time to full closure was 11.4 weeks, with the proportion of completely healed patients rising progressively, reaching 55% by week 11. These findings, from the clinical trial “Freeze-dried amniotic membrane in the treatment of nonhealing wounds”, suggest AMNIODERM+® as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled “Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial”, EUDAMED Nr. CIV-SK-22-10-041146.

Keywords

• medical device
• Vaselinum album
• tulle dressing
• grassy tulle
• amniotic membrane
• chronic wounds