RecruitingNot ApplicableNCT06618612

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


Sponsor

Organogenesis

Enrollment

170 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a special wound dressing called PCMP — which contains a collagen matrix infused with an antimicrobial agent — compared to standard wound care alone, for people with diabetic foot ulcers that have not healed despite prior treatment. Diabetic foot ulcers are a serious complication of diabetes and are a leading cause of amputation. **You may be eligible if...** - You are 18 or older with Type 1 or Type 2 diabetes - Your target wound is at least 1 cm² in area and has been present for at least 4 weeks without healing - The ulcer is on your foot (at least half of it below the ankle bone) - The wound is classified as Wagner Grade 1 or 2 (not deeply infected or gangrenous) - Blood flow to your leg is adequate - If the wound is on the sole of your foot, it has been properly offloaded (pressure relieved) for at least 14 days **You may NOT be eligible if...** - Your wound has a bone or deep tissue infection - Your blood flow to the leg is severely compromised - Your blood sugar is very poorly controlled - You have an active systemic infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard 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.

DEVICEPuraPly 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)

DEVICEPuraPly 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)


Locations(1)

Kent State University, College of Podiatric Medicine

Clevland, Ohio, United States

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NCT06618612


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