A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.

NCT Number	NCT06618612
Lead Sponsor	Organogenesis Collaborators: Serena Group
Conditions	Diabetic Foot Ulcer
Enrollment	170 participants
Start Date	2024-08-19
Primary Completion	2026-08-19 (estimated)
Study Completion	2026-11-19 (estimated)
Updated on ClinicalTrials.gov	2025-04-04