- Design
- Multicentre randomised controlled trial, open comparison with standard care
- Population
- 143 people with diabetes and chronic full-thickness foot wounds
- Primary outcome
- Proportion of wounds completely healed at 12 weeks
- Effect
- 46% (31/68) vs 24% (17/72), p = 0.008 (modified ITT)
A multicentre randomised trial enrolled 143 people with diabetes and chronic full-thickness foot wounds that met prespecified criteria. Patients received standard care alone or standard care plus a composite matrix of ovine forestomach tissue and high-molecular-weight hyaluronic acid. The primary endpoint was complete healing by 12 weeks.
In the modified intention-to-treat analysis, 46% (31 of 68) healed with the matrix against 24% (17 of 72) with standard care alone. Time-to-healing analysis also favoured the matrix, and no unexpected safety events were reported.
The authors flag post-randomisation exclusions, differential withdrawal, and an adjusted comparison that only just reached significance. Advanced wound products are an add-on to offloading, debridement, infection control and revascularisation, not a substitute for them.
- Confirm offloading, debridement, infection control and perfusion are optimised before considering any advanced dressing
- Measure wound area at each visit; an ulcer not shrinking by about half in four weeks needs reassessment
- Check pedal pulses and arrange vascular assessment for any non-healing foot ulcer
- Expect cost and availability to limit matrix products in many Indian centres
Why it matters
It is randomised evidence for one product in a field crowded with uncontrolled case series.
Don't overread it
Exclusions after randomisation and uneven withdrawal leave the adjusted result fragile (p = 0.045).
The statistics, in plain English
Healing roughly doubled, from 24% to 46%, so about one extra wound healed for every five treated. But when patients are removed after randomisation, the groups may no longer be comparable, and an adjusted p-value of 0.045 sits right at the threshold — a small change in who was counted could move it either side.
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