@article{83d21715e6dd4e508e8815e26b958874,
title = "A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers",
abstract = "Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care group (SOC, collagen alginate dressing) at 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridements when needed and an offloading device. The primary endpoint was proportion of full-thickness, non-infected, non-ischaemic wounds healed at 12 weeks, with secondary endpoints including percent area reduction (PAR) and changes in Semmes-Weinstein monofilament testing. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 70% (14/20) of the BBGFM-treated DFUs healed compared with 25% (5/20) treated with SOC alone (adjusted P =.006). Mean PAR at 12 weeks was 79% in the BBGFM group compared with 37% in the SOC group (adjusted P =.027). Mean change in neuropathic score between baseline and up to 12 weeks of treatment was 2.0 in the BBGFM group compared with −0.6 in the SOC group where positive improvement in scores are better (adjusted P =.008). The mean number of BBGFM applications was 6.0. In conclusion, adding BBGFM to SOC significantly improved wound healing with no adverse events related to treatment compared with SOC alone.",
keywords = "complete wound healing, diabetic foot ulcer, glass fibre matrix, randomised controlled trial, resorption",
author = "Armstrong, {David G.} and Orgill, {Dennis P.} and Galiano, {Robert D.} and Glat, {Paul M.} and DiDomenico, {Lawrence A.} and Carter, {Marissa J.} and Zelen, {Charles M.}",
note = "Funding Information: The authors would like to acknowledge Ted Day, former CEO of ETS WoundCare who recently passed away for his discovery of BBGFM and his desire to advance science in wound healing. This study was funded with a grant from ETS WoundCare LLC, North Rolla, Missouri. Funding Information: This study was funded through a research grant from ETS WoundCare provided to the Professional Education and Research Institute (PERI), for which Charles M Zelen, DPM is medical director. David Armstrong, DPM, MD, PhD received research funds from PERI to serve as Principal Investigator for this trial and to design and administrate the trial and also assist with the writing and review of the manuscript. Dennis 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 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 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. Lawrence Didomenico, DPM received research funds and served as a site investigator for this trial and assisted with the writing and review of the manuscript. Marissa Carter, PhD received research funds to provide the statistical analysis plan, and provide the statistical analysis for this trial and assist with the 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. There are no other conflict of interests with any of the authors in relationship to this study, or with regard to ETS WoundCare. IRB conflict of interest statements are on file with PERI. Publisher Copyright: {\textcopyright} 2021 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.",
year = "2022",
month = may,
doi = "10.1111/iwj.13675",
language = "English (US)",
volume = "19",
pages = "791--801",
journal = "International Wound Journal",
issn = "1742-4801",
publisher = "Wiley-Blackwell",
number = "4",
}