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Journal article
A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis
International wound journal, v 19(1), pp 64-75
Jan 2022
PMID: 33942506
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty-three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12 weeks. There were significantly more wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at 12 weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.
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Details
- Title
- A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim 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, USA.Alexander Reyzelman - Center for Clinical ResearchRobert Snyder - Barry UniversityWilliam W Li - Angiogenesis FoundationMarissa Carter - Strategic Solutions, Bozeman, Montana, USA.Charles M Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 19(1), pp 64-75
- Publisher
- Wiley
- Grant note
- 002 / Polarity TE
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:000646546200001
- Scopus ID
- 2-s2.0-85104937304
- Other Identifier
- 991019167967004721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Dermatology
- Surgery