PREPARE trial publication reports improved diabetic foot ulcer closure with PuraPly AM plus standard care
Published in Diseases!, Journals.
Publication date: October 12, 2026.
Organogenesis announced on October 12 the peer-reviewed publication of previously released PREPARE trial results. The paper appeared in the Journal of Wound Care on October 2 and evaluates PuraPly AM, a collagen matrix with the antimicrobial PHMB, added to standard care for hard-to-heal diabetic foot ulcers.
Across 25 US sites, 170 patients were randomised to the product plus standard care (96) or standard care alone (74). Complete closure within 12 weeks, confirmed two weeks later, occurred in 42% versus 27%. The reported absolute difference was 14.6 percentage points (95% confidence interval: 0.15–27.9; p=0.047). No adverse events or serious adverse events were attributed to the product.
Evidence limits: Patients and treating clinicians were unblinded, although independent closure adjudicators were blinded. Organogenesis funded the trial, and several authors disclosed relevant affiliations. The short follow-up does not establish reduced amputations or durable protection against ulcer recurrence. The product was evaluated as an addition to standard care.
Sources: PREPARE paper, October 2, 2026; Organogenesis announcement, October 12, 2026.