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
← catalyst calendarSponsored by Organogenesis (industry) · ORGO — their whole pipeline →. With Serena Group.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
170estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-19 | actual | When the study began enrolling |
| Primary completion | 2026-08-19 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-19 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-04-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Diabetic Foot Ulcer
Interventions
- Other: Standard of Care
- Device: PuraPly AM
- Device: PuraPly XT
Primary outcome
what the primary-completion date above is the date OFDetermine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
measured 12 weeks
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