Native collagen matrix plus PHMB antimicrobial in hard-to-heal diabetic foot ulcers: results from the PREPARE randomised controlled trial.
Leandro Tapia Garcia, Jaminelli Banks, Manuel Rodriguez et al.
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In 30 seconds
The PREPARE prospective, multicentre randomised controlled trial compared purified native type 1 collagen extracellular matrix plus polyhexamethylene biguanide (PCMP) with standard care (SoC) alone in patients with hard-to-heal diabetic foot ulcers. Among 170 randomised patients at 25 US sites, complete wound closure by 12 weeks occurred in 42% with PCMP+SoC and 27% with SoC alone (absolute difference 14.6%; 95% confidence interval: 0.15%, 27.9%; p=0.047). Mean percentage area reduction was also greater with PCMP+SoC. No adverse or serious adverse events were attributed to PCMP.
Key findings
- Twelve-week complete closure occurred in 42% with PCMP+SoC versus 27% with SoC alone (absolute difference 14.6%; 95% confidence interval: 0.15%, 27.9%; p=0.047).
- Mean wound area reduction was 75.23% with PCMP+SoC versus 58.06% with SoC alone.
- No adverse events or serious adverse events were attributed to PCMP.
Why it matters
Hard-to-heal diabetic foot ulcers can be challenging to close with standard wound care. In this randomised trial, adding PCMP was associated with a higher proportion of ulcers achieving confirmed closure within 12 weeks and greater mean area reduction. These results provide comparative evidence for an adjunctive wound-care option in the studied population, while the findings should be interpreted within the trial’s eligibility criteria and follow-up period.
What to keep in mind
Follow-up for the primary endpoint was limited to 12 weeks, with confirmation two weeks later; the abstract does not report longer-term outcomes.