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Study details
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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

Organogenesis
NCT IDNCT06618612ClinicalTrials.gov data as of Apr 2026
Target enrollment

170

Study length

about 2.3 years

Ages

18+

Locations

1 site in OH

What this study is about

Researchers are testing whether a new treatment, PuraPly AM or XT, combined with standard care helps heal non-healing diabetic foot ulcers better than standard care alone. The trial will last for 822 days and involve approximately 170 participants.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Standard of Care
  • 2.Use PuraPly AM
  • 3.Use PuraPly XT

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Secondary: The number of adverse events.