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NCT06618612 · ClinicalTrials.gov registry record · NA
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 NA study of Diabetic Foot Ulcer, sponsored by Organogenesis.
- Recruiting
- Registry status
- NA
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT06618612: Recruiting NA study of Diabetic Foot Ulcer, sponsored by Organogenesis.
NCT06618612 is a NA study of Diabetic Foot Ulcer that is actively recruiting participants, run by Organogenesis. The registered enrollment target is 170 participants, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06618612, a NA study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Organogenesis.
- RECRUITING
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The percentage of target ulcers achieving complete wound closure in 12 weeks
Conditions Studied
Interventions
- OTHER Standard of Care
- DEVICE PuraPly AM
- DEVICE PuraPly XT
Study Locations (1)
Ohio
- Kent State University, College of Podiatric Medicine - Clevland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2026-11-19 |
| Phase | NA |
What NCT06618612 shows while recruiting
NCT06618612 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT06618612 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06618612 about?
NCT06618612 is a clinical study titled "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". 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.
What is the current status of trial NCT06618612?
This trial is currently recruiting. It is a NA study. The enrollment target is 170 participants. The study started on 2024-08-19. Estimated completion is 2026-11-19.
What conditions does trial NCT06618612 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06618612?
The interventions under investigation include: Standard of Care (OTHER), PuraPly AM (DEVICE), PuraPly XT (DEVICE).
Who is sponsoring clinical trial NCT06618612?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06618612 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06618612's enrollment target sits among peer trials
170 22nd of 67 higher than 44 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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-
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