RESUMO
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.
RESUMO
An inability of the human body to heal acute wounds under certain conditions results in the formation of chronic ulcers. Chronic wounds not only cause significant pain and discomfort for patients but also serve as an entry for microorganisms into the human body, which can result in serious life-threatening problems and become a significant burden for the patients and society. The current work present results of a multicentre prospective observational study demonstrating the use of a lyophilized amniotic membrane (AM) in the treatment of chronic wounds (various etiologies). Lyophilized AM produced under the commercial brand Amnioderm® was used as an allograft material for therapy of chronic wounds, in addition to chronic ulcer standard-of-care (SoC) protocols. The duration of wounds considered for the application of AM ranged between 2 months and 11 years. In total, 16 patients were enrolled to the study, of which eight were completely healed, six demonstrated a significantly reduced ulcer size, and two did not respond to the AM therapy. The current study unambiguously demonstrates an effective alternative to the standard of chronic wound care and confirms a significant effect of the AM application for chronic wound management as a new SoC.