Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers.


Journal

International wound journal
ISSN: 1742-481X
Titre abrégé: Int Wound J
Pays: England
ID NLM: 101230907

Informations de publication

Date de publication:
Oct 2020
Historique:
received: 02 03 2020
revised: 23 04 2020
accepted: 26 04 2020
pubmed: 27 5 2020
medline: 19 8 2021
entrez: 27 5 2020
Statut: ppublish

Résumé

Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open-label, single-arm feasibility study. Eleven patients with DFUs extending up to tendon, bone, or capsule received a single topical application of AHSC. Closure was documented weekly with high-resolution digital photography and wound planimetry. All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days. The mean percent area reduction for all 11 wounds at 4 weeks was 83%. There were no adverse events related to the AHSC treatment site. This pilot study demonstrated AHSC may be a viable single application topical intervention for DFUs and warrants investigation in larger, controlled studies.

Identifiants

pubmed: 32453512
doi: 10.1111/iwj.13404
pmc: PMC7540349
doi:

Types de publication

Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1366-1375

Subventions

Organisme : NCATS NIH HHS
ID : UL1 TR001855
Pays : United States
Organisme : PolarityTE
ID : Grant001

Informations de copyright

© 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

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Auteurs

David G Armstrong (DG)

Keck School of Medicine, University of Southern California, California, Los Angeles, USA.

Dennis P Orgill (DP)

Brigham and Women's Hospital, Boston, Massachusetts, USA.

Robert Galiano (R)

Northwestern University School of Medicine, Chicago, Illinois, USA.

Paul M Glat (PM)

Drexel University, Philadelphia, Pennsylvania, USA.

Marissa Carter (M)

Strategic Solutions, Inc., Cody, Wyoming, USA.

Charles M Zelen (CM)

The Professional Education and Research Institute (PERI), Roanoke, Virginia, USA.

William W Li (WW)

The Angiogenesis Foundation, Cambridge, Massachusetts, USA.

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