Clinical Evaluation of AMNIODERM+(R) Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62156489%3A43210%2F24%3A43925869" target="_blank" >RIV/62156489:43210/24:43925869 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.3390/biotech13030036" target="_blank" >https://doi.org/10.3390/biotech13030036</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/biotech13030036" target="_blank" >10.3390/biotech13030036</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Clinical Evaluation of AMNIODERM+(R) Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial

Popis výsledku v původním jazyce

Chronic wounds result from the body&apos;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+(R), 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+(R). 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 &quot;Freeze-dried amniotic membrane in the treatment of nonhealing wounds&quot;, suggest AMNIODERM+(R) as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled &quot;Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial&quot;, EUDAMED Nr. CIV-SK-22-10-041146.

Název v anglickém jazyce

Clinical Evaluation of AMNIODERM+(R) Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial

Popis výsledku anglicky

Chronic wounds result from the body&apos;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+(R), 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+(R). 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 &quot;Freeze-dried amniotic membrane in the treatment of nonhealing wounds&quot;, suggest AMNIODERM+(R) as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled &quot;Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial&quot;, EUDAMED Nr. CIV-SK-22-10-041146.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30402 - Technologies involving the manipulation of cells, tissues, organs or the whole organism (assisted reproduction)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

BioTech

ISSN

2673-6284

e-ISSN

2673-6284

Svazek periodika

13

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

13

Strana od-do

36

Kód UT WoS článku

001326120600001

EID výsledku v databázi Scopus

2-s2.0-85205062785