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Journal article
A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers
International wound journal, v 19(4), pp 791-801
21 Aug 2021
PMID: 34418302
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- 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
- Creators
- David G. Armstrong - University of Southern CaliforniaDennis P. Orgill - Professional Education and Research InstituteRobert D. Galiano - Northwestern UniversityPaul M. Glat - Drexel UniversityLawrence A. DiDomenico - Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USA.Marissa J. Carter - Strategic Solutions, Inc., Bozeman, Montana, USA.Charles M. Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 19(4), pp 791-801
- Publisher
- Wiley
- Number of pages
- 11
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:000686919100001
- Scopus ID
- 2-s2.0-85113153606
- Other Identifier
- 991019167878904721
UN Sustainable Development Goals (SDGs)
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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