NCT06618612

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

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

At least 170 subjects with a chronic DFU will be randomized 1.4:1:1 to the SOC group, PuraPly AM + SOC, or PuraPly XT + SOC. Following screening and randomization, subjects shall be seen weekly for up to 12 weeks. For subjects that heal, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	Standard of Care	Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.
DEVICE	PuraPly AM	PuraPly Antimicrobial Wound Matrix is a 2-layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
DEVICE	PuraPly XT	PuraPly Antimicrobial XT Wound Matrix is a 5- layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)

Timeline

• Start date: 2024-08-19
• Primary completion: 2026-08-19
• Completion: 2026-11-19
• First posted: 2024-10-01
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study