@article{cde69102f2d74a7bbab5936f02a94520,
title = "An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers",
abstract = "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.",
author = "Armstrong, {David G.} and Orgill, {Dennis P.} and Galiano, {Robert D.} and Glat, {Paul M.} and Kaufman, {Jarrod P.} and Carter, {Marissa J.} and Zelen, {Charles M.}",
note = "Funding Information: This study was funded through a research grant from Geistlich Pharma AG, provided to the Professional Education and Research Institute (PERI), which Charles M Zelen, DPM, is medical director. David Armstrong, DPM, MD, PhD, received research funds from PERI to design and administrate the trial and also assist with the writing and review of the manuscript. Dennis P. Orgill, MD, PhD, received research funds to serve as a validating/adjudicating plastic surgeon to review study photos and assist with the writing and review of the manuscript. Robert D. Galiano, MD, received research funds to serve as a validating/adjudicating plastic surgeon to review study photos and assist with the writing and review of the manuscript. Paul M. Glat, MD, received research funds to serve as a validating/adjudicating plastic surgeon to review study photos and assist with the writing and review of the manuscript. Jarrod P. Kauffman, MD, received research funds to assist in study design and in manuscript preparation. Marissa Carter, PhD, received research funds to provide the statistical analysis plan, and provide the statistical analysis for this trial and assist with writing of the result section of the manuscript. Charles M Zelen, DPM, is the medical director of the PERI and his company received research funds to administrate the clinical trial and write the paper for publication. Publisher Copyright: {\textcopyright} 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.",
year = "2020",
month = aug,
day = "1",
doi = "10.1111/iwj.13353",
language = "English (US)",
volume = "17",
pages = "966--973",
journal = "International Wound Journal",
issn = "1742-4801",
publisher = "Wiley-Blackwell",
number = "4",
}