Study of PuraPly AM and PuraPly XT for Diabetic Foot Ulcers

This study is looking at new ways to help non-healing diabetic foot ulcers (sores on your feet due to diabetes) close. It compares two types of wound dressings, PuraPly AM and PuraPly XT, along with standard care, to standard care alone. Standard care includes things like wound cleaning, managing infection, and taking pressure off the foot. You could be eligible if you are at least 18 years old, have type 1 or 2 diabetes, and have a foot ulcer that's been there for at least four weeks and meets certain size and location requirements. The main goal is to see if PuraPly AM or PuraPly XT helps your ulcer close completely within 12 weeks. The study plans to enroll 170 people, but its current status is unclear.

Study design
This is a randomized, controlled study comparing different treatments. About 170 participants will be assigned to receive standard care, PuraPly AM plus standard care, or PuraPly XT plus standard care.
What's involved
You would have weekly visits for up to 12 weeks. If your wound heals, you'll have one more visit two weeks later to confirm it stays closed.
Compensation
Not stated in the trial record.
Follow-up
After your wound heals, there will be a follow-up visit two weeks later to confirm it remains closed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
NAAges 18+InterventionalTreatment
Organogenesis
~170 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Standard of CarePuraPly AMPuraPly XT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
Measured over 12 weeks
Diabetic Foot Ulcer
1 sites across 1 states
Ohio1
  • Maribel Henao · STUDY_DIRECTOR · Organogenesis

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  • Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure12 weeks

    The percentage of target ulcers achieving complete wound closure in 12 weeks