Clinical Evaluation of AMNIODERM+<sup>®</sup> Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial
Iveta Schmiedova,
Petr Slama,
Alena Dembickaja,
Beata Kozova,
Vendula Hyneckova,
Sona Gogolkova,
Elen Stastna,
Michal Zahradnicek,
Stefan Savic,
Arash Davani,
Edward Hulo,
Emil Martinka
Affiliations
Iveta Schmiedova
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Petr Slama
Laboratory of Animal Immunology and Biotechnology, Department of Animal Morphology, Physiology and Genetics, Faculty of AgriSciences, Mendel University in Brno, Zemedelska 1, 613 00 Brno, Czech Republic
Alena Dembickaja
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Beata Kozova
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Vendula Hyneckova
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Sona Gogolkova
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Elen Stastna
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Michal Zahradnicek
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Stefan Savic
BioHealing s.r.o., Dr. Slabihoudka 6232/11, 708 00 Ostrava, Czech Republic
Arash Davani
National Institute of Endocrinology and Diabetology, Kollárová 282/3, 034 91 Ľubochňa, Slovakia
Edward Hulo
National Institute of Endocrinology and Diabetology, Kollárová 282/3, 034 91 Ľubochňa, Slovakia
Emil Martinka
National Institute of Endocrinology and Diabetology, Kollárová 282/3, 034 91 Ľubochňa, Slovakia
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.