Borate-Based Bioactive Glass Demonstrates Healing Benefit in Diabetic Foot Ulcers in Randomized Controlled Trial #ActAgainstAmputation

A new multicenter randomized controlled trial (RCT) from our combined team, published in the International Wound Journal, has reported that a borate-based bioactive glass fiber matrix (BBGFM) appears to significantly improve healing outcomes in people with chronic, non-healing non-infected, non-ischemic full-thickness diabetic foot ulcers (DFUs).

Study Design

The trial enrolled 148 participants across 14 U.S. sites with chronic, full-thickness, non-infected, non-ischemic DFUs. Patients were randomized to receive either standard of care (SOC) alone or SOC plus weekly application of the bioactive glass fiber matrix (Mirragen Advanced Wound Matrix, ETS Wound Care). The primary endpoint was complete wound closure at 12 weeks, with secondary endpoints including time to closure, wound area reduction, pain, neuropathy, and quality of life.

Key Findings

Improved Healing Rates: In the modified intent-to-treat population, 48% of patients receiving BBGFM plus SOC achieved complete healing by 12 weeks, compared to 24% in the SOC-only group (p=0.007).
Per Protocol Results: Among patients completing the study as planned, 73% treated with BBGFM healed versus 42% in the SOC group (p=0.007).
Faster Healing: Mean time to closure was shortened by more than a week in the BBGFM group (9.1 weeks vs. 10.4 weeks, adjusted p=0.042).
Safety Profile: Adverse events were consistent with expectations for this patient population, and no unexpected safety signals emerged.

Mechanism and Potential Impact

Borate-based bioactive glass is designed to mimic the microstructure of a fibrin clot, supporting cellular infiltration, collagen deposition, angiogenesis, and antimicrobial activity. Unlike many cellular or tissue-based products, it is synthetic, shelf-stable at room temperature for up to five years, and intrinsically antimicrobial—features that may reduce logistical barriers and cost of care.

Implications

The trial provides strong evidence that BBGFM can accelerate healing in DFUs, reinforcing results from earlier pilot studies. Given the global burden of DFUs—an estimated 18.6 million new cases annually and a 5-year mortality rate exceeding many cancers—advances like this represent an important addition to the treatment armamentarium.

Why do we use Wagner classification in this study? While most of us know that this is not a system used in most limb preservation programs and long ago been superseded by other systems, it is used by insurance companies to determine coverage.

Next steps:

Future investigations should examine whether this bioactive glass technology can extend benefits to deeper or more complex wounds, venous leg ulcers, or surgical sites.

📄 Full citation:
Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. 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. 2025;22:e70763. doi: 10.1111/iwj.70763.