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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

NCT06618612 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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)

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Maribel Henao · Organogenesis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2026-08-19
Completion
2026-11-19
FDA Device
Yes

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618612 on ClinicalTrials.gov