PREPARE multicenter trial finds native collagen matrix with PHMB significantly boosts 12-week closure in hard-to-heal diabetic foot ulcers
AI-summarized from the linked source. Educational brief, not medical advice.
Brief summary
In the 25-site PREPARE randomized controlled trial of 170 patients with hard-to-heal diabetic foot ulcers, adding a native type 1 collagen matrix with PHMB antimicrobial to standard care significantly increased complete wound closure from 27% to 42% at 12 weeks.
What NurseJet pulled from the source
Chronic diabetic foot ulcers (DFUs) present major healing hurdles due to excessive matrix metalloproteinase activity, bacterial colonization, and impaired extracellular matrix synthesis. The prospective, multicenter PREPARE randomized controlled trial evaluated 170 patients with hard-to-heal DFUs (1–25 cm²) across 25 United States clinical sites. Patients who achieved 40% or greater wound area reduction during a 4-week screening phase were excluded to isolate genuinely non-responsive ulcers. Participants were randomized to receive purified native type 1 collagen extracellular matrix with polyhexamethylene biguanide (PCMP) plus standard of care (SoC; n=96) versus SoC alone (n=74; consisting of sharp debridement, saline cleansing, moisture-balancing dressings, and pressure offloading). At 12 weeks, complete confirmed wound closure was significantly higher in the PCMP group (42% vs 27%; absolute difference 14.6%; 95% CI 0.15% to 27.9%; P = 0.047). Mean percent area reduction was also superior with PCMP (75.23% vs 58.06%), with zero adverse events linked to the collagen matrix.
Why this matters for nurses
Wound care and inpatient nurses caring for patients with diabetes recognize that stalled foot ulcers pose severe risks for osteomyelitis, sepsis, and lower-extremity amputation. When standard offloading and moist wound healing fail to achieve progress over four weeks, this robust trial shows that escalating to a dual-action collagen matrix with PHMB antimicrobial protection safely accelerates wound closure.
Bedside takeaway
In a 25-site trial of 170 patients with hard-to-heal diabetic foot ulcers, adding a native collagen matrix with PHMB to standard wound care increased 12-week complete closure from 27% to 42% (p=0.047).
Key takeaways
- Multicenter prospective randomized trial enrolled 170 diabetic patients with hard-to-heal foot ulcers across 25 clinical centers in the United States.
- Excluded patients with 40% or greater area reduction during a 4-week screening period to focus strictly on recalcitrant wounds.
- Complete 12-week wound closure was achieved by 42% of patients treated with native collagen-PHMB matrix compared to 27% with standard care alone (P = 0.047).
- Mean percent area reduction was higher with collagen-PHMB (75.23% vs 58.06%), with no adverse events attributed to the bioactive dressing.
Practice implications
- Assess diabetic foot ulcers for stagnant healing trajectories (lack of 40% area reduction over 4 weeks of standard offloading and dressing care). For non-healing wounds meeting criteria, collaborate with the wound specialist or provider regarding initiating advanced collagen-antimicrobial extracellular matrix dressings while maintaining strict offloading adherence.
Limitations & cautions
- Excluded ulcers with active osteomyelitis, severe ischemia, or excessive wound area (>25 cm²); trial was supported by the product manufacturer; required 4-week screening period.
- AI-summarized from the linked source. Review the original article before applying to practice.
Citations
Exact source links
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Journal of Wound Care (PubMed)
Journal of Wound Care (PubMed). Native collagen matrix plus PHMB antimicrobial in hard-to-heal diabetic foot ulcers: results from the PREPARE randomised controlled trial.
https://pubmed.ncbi.nlm.nih.gov/42842703/
Professional education only
