Journal article
A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis
International wound journal, v 20(10), pp 4083-4096
01 Dec 2023
PMID: 37402533
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Abstract A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) ( p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks ( p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
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Details
- Title
- A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis
- Creators
- David G. Armstrong - University of Southern CaliforniaDennis P. Orgill - Brigham and Women's HospitalRobert Galiano - Northwestern UniversityPaul M. Glat - Drexel UniversityLawrence Didomenico - Lower Extremity Institute of Research and Therapy Youngstown Ohio USANikolai A. Sopko - PolarityTE Salt Lake City Utah USAEdward W. Swanson - PolarityTE Salt Lake City Utah USAFelix Sigal - University Foot & Ankle InstituteRobert Snyder - Barry UniversityWilliam W. Li - Angiogenesis FoundationMarissa Carter - Strategic Solutions Consulting (United States)Charles M. Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 20(10), pp 4083-4096
- Publisher
- Wiley
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:001021918200001
- Scopus ID
- 2-s2.0-85164339570
- Other Identifier
- 991021838157904721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Dermatology
- Surgery