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Journal article
Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi‐centre clinical trial
International wound journal, v 19(5), pp 1197-1209
Aug 2022
PMID: 35001559
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from a pilot study using a novel purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot ulcers (DFUs), we designed a prospective, multi‐centre randomised trial comparing outcomes of PRBM at 12 weeks compared with a standard of care (SOC) using a collagen alginate dressing. The primary endpoint was percentage of wounds closed after 12 weeks. Secondary outcomes included assessments of complications, healing time, quality of life, and cost to closure. Forty patients were included in an intent‐to‐treat (ITT) and per‐protocol (PP) analysis, with 39 completing the study protocol (n = 19 PRBM, n = 20 SOC). Wounds treated with PRBM were significantly more likely to close than wounds treated with SOC (ITT: 85% vs 30%, P = .0004, PP: 94% vs 30% P = .00008), healed significantly faster (mean 37 days vs 67 days for SOC, P = .002), and achieved a mean wound area reduction within 12 weeks of 96% vs 8.9% for SOC. No adverse events (AEs) directly related to PRBM treatment were reported. Mean PRBM cost of healing was $1731. Use of PRBM was safe and effective for treatment of chronic DFUs.
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Details
- Title
- Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi‐centre clinical trial
- Creators
- David G. Armstrong - University of Southern CaliforniaDennis P. Orgill - Professional Education and Research InstituteRobert D. Galiano - Northwestern UniversityPaul M. Glat - St. Christopher's Hospital for ChildrenJarrod P. Kaufman - McGowan Institute for Regenerative MedicineMarissa J. Carter - Strategic Solutions, Inc. Bozeman Montana USALawrence A. DiDomenico - Lower Extremity Institute for Research and Therapy Youngstown Ohio USACharles M. Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 19(5), pp 1197-1209
- Publisher
- Blackwell Publishing Ltd
- Number of pages
- 13
- Grant note
- Geistlich Pharma (002)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:000740541800001
- Scopus ID
- 2-s2.0-85122634310
- Other Identifier
- 991019167937204721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Dermatology
- Surgery