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Journal article
A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial
International wound journal, v 22(10), e70763
Oct 2025
PMID: 41014175
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
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Details
- Title
- A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial
- Creators
- David G Armstrong - University of Southern CaliforniaDennis P Orgill - Professional Education and Research InstituteRobert D Galiano - Northwestern UniversityJohn Lantis - Mount Sinai HospitalPaul M Glat - Drexel UniversityMarcus Gitterle - WoundCentrics, LLC, New Braunfels, Texas, USAMarissa J Carter - Strategic Solutions, Inc., Cody, Wyoming, USANathan Young - Foot and Ankle Specialists of the MidAtlantic, Rockville, Maryland, USACharles M Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 22(10), e70763
- Publisher
- Wiley
- Number of pages
- 13
- Grant note
- 003 / ETS Wound Care
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:001623046200001
- Scopus ID
- 2-s2.0-105017416239
- Other Identifier
- 991022118672704721
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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