Journal of wound care
Native collagen matrix plus PHMB antimicrobial in hard-to-heal diabetic foot ulcers: results from the PREPARE randomised controlled trial
By Garcia LT, Banks J, Rodriguez M and 7 others.
Abstract
Objective
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).
Method
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).
