Logo image
Back
An observational pilot study using a purified reconstituted bilayer matrix to treat non‐healing diabetic foot ulcers
Journal article   Open access   Peer reviewed

An observational pilot study using a purified reconstituted bilayer matrix to treat non‐healing diabetic foot ulcers

David G. Armstrong, Dennis P. Orgill, Robert D. Galiano, Paul M. Glat, Jarrod P. Kaufman, Marissa J. Carter and Charles M. Zelen
International wound journal, v 17(4), pp 966-973
07 Apr 2020
DOI: https://doi.org/10.1111/iwj.13353
PMID: 32266774
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1111/iwj.13353View
Published, Version of Record (VoR)CC BY-NC-ND V4.0,  Open

Abstract

Original
Diabetic foot ulcers (DFUs) have significant clinical impact and carry a substantial economic burden. Patients with DFUs that are refractory to standard wound care are at risk for major complications, including infection and amputation and have an increased risk of mortality. This study evaluated the safety and preliminary efficacy of a novel decellularised purified reconstituted bilayer matrix (PRBM) in treating DFUs. Ten diabetic patients with refractory wounds that failed to heal after at least 4 weeks of standard wound care were studied in this Institutional Review Board approved trial. Ten consecutive wounds were treated weekly with the PRBM for up to 12 weeks. At each weekly visit, the wound was evaluated, photographed, and cleaned, followed by application of new graft if not completely epithelialised. Assessment included measurement of the wound area and inspection of the wound site for signs of complications. The primary outcome measure was wound closure, as adjudicated by independent reviewers. Secondary outcomes included assessment of overall adverse events, time to closure, percent area reduction, and the cost of product(s) used. Nine of 10 patients achieved complete wound closure within 4 weeks, and 1 did not heal completely within 12 weeks. The mean time to heal was 2.7 weeks. The mean wound area reduction at 12 weeks was 99%. No adverse events nor wound complications were observed. These early clinical findings suggest that the PRBM may be an effective tool in the treatment of diabetic foot ulcers.

Metrics

12 Record Views
14 citations in Web of Science
11 citations in Scopus

Details

UN Sustainable Development Goals (SDGs)

This publication has contributed to the advancement of the following goals:

#3 Good Health and Well-Being

InCites Highlights

Data related to this publication, from InCites Benchmarking & Analytics tool:

Collaboration types
Domestic collaboration
Web of Science research areas
Dermatology
Surgery
Logo image