Organogenesis Trial Demonstrates Statistically Significant DFU Closure in 12 Weeks
Organogenesis achieved statistical significance (p<0.0477) for diabetic foot ulcer closure at 12 weeks in a 170-patient randomized trial of PuraPly AM plus standard of care versus standard of care alone. The results bolster clinical evidence to support future coverage policies and commercial adoption of PuraPly AM.
1. Trial Details
The multi-center, prospective randomized controlled trial enrolled 170 patients with non-healing diabetic foot ulcers to compare PuraPly AM plus standard of care against standard of care alone over 12 weeks.
2. Key Findings
The study achieved its primary endpoint with statistically significant (p<0.0477) DFU wound closure at 12 weeks in the PuraPly AM group versus control, reinforcing the product’s efficacy in promoting wound healing.
3. Clinical Implications
These findings expand the clinical evidence base for PuraPly AM, supporting plans to publish in a peer-reviewed journal and to advocate for inclusion in coverage and reimbursement policies, potentially accelerating market adoption.
4. Product Profile
PuraPly AM combines a cross-linked native collagen matrix with PHMB antimicrobial technology, offering a differentiated approach to manage bioburden and enhance healing in advanced wound care.