Clinical Evaluation of AMNIODERM+(R) Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Clinical Evaluation of AMNIODERM+(R) Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial
Original language description
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+(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 "Freeze-dried amniotic membrane in the treatment of nonhealing wounds", 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 "Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial", EUDAMED Nr. CIV-SK-22-10-041146.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30402 - Technologies involving the manipulation of cells, tissues, organs or the whole organism (assisted reproduction)
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
BioTech
ISSN
2673-6284
e-ISSN
2673-6284
Volume of the periodical
13
Issue of the periodical within the volume
3
Country of publishing house
CH - SWITZERLAND
Number of pages
13
Pages from-to
36
UT code for WoS article
001326120600001
EID of the result in the Scopus database
2-s2.0-85205062785