Reviewed clinical summary · Source-linked · Educational use only

Borate Bioactive Glass Accelerates Diabetic Foot Ulcer Healing: Randomized Controlled Trial

Clinical Bottom Line

A multicentre RCT finds borate bioactive glass fibre matrix doubles 12-week healing of superficial diabetic foot ulcers versus standard care. PICO summary and commentary.

Summary: In a randomised trial in chronic, non-healing Wagner grade 1 diabetic foot ulcers, adding a borate-based bioactive glass fibre matrix to standard care roughly doubled the proportion healed at 12 weeks, with only minor local adverse events.

PICO Summary

ElementDetail
Population133 adults with chronic, non-healing Wagner grade 1 diabetic foot ulcers; multicentre RCT, USA.
InterventionBorate-based bioactive glass fibre matrix (BBGFM) plus standard of care for 12 weeks.
ComparisonStandard of care alone for 12 weeks.
OutcomeIn the modified intent-to-treat analysis, 48% (32/67) healed at 12 weeks with BBGFM versus 24% (16/66) with standard care (p=0.007). In the per-protocol population, 73% (32/44) versus 42% (16/38) healed (p=0.007). Adverse events were minor and local.
RCT Int Wound J · 2025

Borate bioactive glass for diabetic foot ulcers

RCT · type 2 diabetes · 12 weeks

Trial design
Wagner grade 1 foot ulcers Enrolled & assessed RANDOMISED 1:1 BBGFM + SOC Bioactive glass matrix n = 67 Standard care Standard of care alone n = 66 Complete ulcer healing at 12 weeks (mITT)
Proportion reaching endpoint
RR 2.0 % healed at 12 weeks 48% BBGFM + SOC 24% Standard care ARR+24 pts (ARR)
Healed (BBGFM)
48%
32/67 mITT
Healed (SOC)
24%
16/66 mITT
Absolute gain
+24 pts
p=0.007
Per-protocol
73% vs 42%
p=0.007
⬡ Bottom Line

Adding a borate bioactive glass fibre matrix to standard care doubled 12-week healing of superficial diabetic foot ulcers, from 24% to 48%. Benefit is shown only for Wagner grade 1 ulcers as an adjunct to sound wound-care basics.

Expert Commentary

This is a positive and reasonably persuasive trial in an area where good news is scarce, since standard care heals only a minority of chronic diabetic foot ulcers at twelve weeks. The result is clinically meaningful rather than merely statistical: a doubling of complete closure in the modified intent-to-treat analysis, from 24% to 48%, with a consistent per-protocol effect, and the biological rationale is coherent, as borate glass releases ions that promote angiogenesis and collagen synthesis while the fibre scaffold supports tissue ingrowth and moisture balance. The honest boundary is wound severity: this was tested only in superficial Wagner grade 1 ulcers, so the benefit cannot be assumed for deeper grade 2 to 4 wounds that carry the greatest amputation risk, and as an adjunct it presupposes the fundamentals of offloading, debridement, infection control, perfusion, and glycaemic management rather than replacing them. Can I use this with my patients? Yes, in the right niche. For a patient with a superficial diabetic foot ulcer that has stalled despite good standard care and adequate perfusion, this supports considering bioactive glass as an advanced option layered onto, not instead of, sound wound-care basics, while awaiting evidence in deeper ulcers and on amputation outcomes.

References

Armstrong DG, Orgill DP, Galiano RD, et al. A borate-based bioactive glass advances wound healing in non-healing Wagner grade 1 diabetic foot ulcers: a randomised controlled clinical trial. Int Wound J. 2025;22(10):e70763. doi:10.1111/iwj.70763

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