Organogenesis’ PuraPly AM Shows Statistically Significant Ulcer Closure in 170-Patient Trial
Organogenesis’ PuraPly AM achieved statistically significant (p<0.0477) closure of diabetic foot ulcers in a 170-patient trial at 12 weeks, outperforming standard care alone. These findings strengthen clinical evidence for future coverage and commercialization of the collagen-based, PHMB-antimicrobial therapy.
1. Trial Design and Endpoint Achievement
The multi-center randomized controlled trial enrolled 170 patients with non-healing diabetic foot ulcers and compared PuraPly AM plus standard of care to standard care alone. The study met its primary endpoint of ulcer closure at 12 weeks with a statistically significant p-value below 0.0477, demonstrating superior efficacy over standard treatment.
2. PuraPly AM Profile and Mechanism
PuraPly AM combines a cross-linked native collagen matrix with polyhexamethylene biguanide (PHMB) antimicrobial to manage wound bioburden and support tissue regeneration. This patent-protected formulation differentiates PuraPly AM from other skin substitutes by integrating antimicrobial action directly within the collagen scaffold.
3. Implications for Coverage and Commercialization
These positive results add to the clinical evidence base for PuraPly AM and are expected to support its inclusion in future coverage policies. Organogenesis plans to publish the full study in a peer-reviewed journal, which may accelerate adoption and reimbursement discussions for the therapy.