Native collagen matrix plus PHMB antimicrobial in hard-to-heal diabetic foot ulcers: results from the PREPARE randomised controlled trial.
PREPARE was a prospective, multicentre, randomised controlled trial evaluating purified native type 1 collagen extracellular matrix plus polyhexamethylene biguanide (PCMP) with standard of care (SoC) versus SoC alone in patients with hard-to-heal diabetic foot ulcers (DFUs).
Across 25 US sites, patients with type 1 or type 2 diabetes and hard-to-heal DFUs measuring 1-25cm2 were enrolled. Patients demonstrating ≥40 percent area reduction (PAR) during four weeks of screening were excluded to restrict the study population to those with hard-to-heal wounds. SoC included sharp debridement, saline cleansing, use of moisture-balancing dressings and offloading. The primary endpoint was complete wound closure within 12 weeks, confirmed two weeks later. Secondary endpoints included time to closure, PAR and adverse events (AEs).
A total of 170 patients were randomised (PCMP+SoC, n=96; SoC alone, n=74). Complete wound closure occurred in 42% of patients receiving PCMP+SoC versus 27% of patients receiving SoC alone (absolute difference 14.6%; 95% confidence interval: 0.15%, 27.9%; p=0.047). Mean PAR was greater with PCMP+SoC than with SoC alone (75.23% versus 58.06%, respectively). No AEs or serious AEs were attributed to PCMP.
In this study, use of PCMP+SoC significantly improved 12-week closure outcomes in patients with hard-to-heal DFUs compared with SoC alone, supporting its use as an adjunctive antimicrobial barrier for these types of wounds.
Across 25 US sites, patients with type 1 or type 2 diabetes and hard-to-heal DFUs measuring 1-25cm2 were enrolled. Patients demonstrating ≥40 percent area reduction (PAR) during four weeks of screening were excluded to restrict the study population to those with hard-to-heal wounds. SoC included sharp debridement, saline cleansing, use of moisture-balancing dressings and offloading. The primary endpoint was complete wound closure within 12 weeks, confirmed two weeks later. Secondary endpoints included time to closure, PAR and adverse events (AEs).
A total of 170 patients were randomised (PCMP+SoC, n=96; SoC alone, n=74). Complete wound closure occurred in 42% of patients receiving PCMP+SoC versus 27% of patients receiving SoC alone (absolute difference 14.6%; 95% confidence interval: 0.15%, 27.9%; p=0.047). Mean PAR was greater with PCMP+SoC than with SoC alone (75.23% versus 58.06%, respectively). No AEs or serious AEs were attributed to PCMP.
In this study, use of PCMP+SoC significantly improved 12-week closure outcomes in patients with hard-to-heal DFUs compared with SoC alone, supporting its use as an adjunctive antimicrobial barrier for these types of wounds.
Authors
Garcia Garcia, Banks Banks, Rodriguez Rodriguez, Cazzell Cazzell, Caporusso Caporusso, Cole Cole, Shi Shi, Cook Cook, Tramelli Tramelli, Serena Serena
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