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NCT05506215 · ClinicalTrials.gov registry record · NA
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
A NA study, sponsored by PolyNovo Biomaterials Pty.
- Terminated
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT05506215: Clinical Trial NA study, sponsored by PolyNovo Biomaterials Pty.
NCT05506215 is a NA study that was terminated before completion, run by PolyNovo Biomaterials Pty. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05506215, a NA study, was terminated before completion, sponsored by PolyNovo Biomaterials Pty.
- TERMINATED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment
Primary Outcome
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart
Interventions
- DEVICE SynPath Acellular Dermal Matrix plus Off-loading Device
- DEVICE Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-07-10 |
| Est. Completion | 2024-02-26 |
| Phase | NA |
Why NCT05506215 stopped before completion
NCT05506215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which SynPath Acellular Dermal Matrix plus Off-loading Device is the first listed.
NCT05506215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05506215 about?
NCT05506215 is a clinical study titled "Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers". The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment
What is the current status of trial NCT05506215?
This trial is currently terminated. It is a NA study. The enrollment target is 25 participants. The study started on 2022-07-10. Estimated completion is 2024-02-26.
What interventions are being tested in trial NCT05506215?
The interventions under investigation include: SynPath Acellular Dermal Matrix plus Off-loading Device (DEVICE), Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device (DEVICE).
Who is sponsoring clinical trial NCT05506215?
This trial is sponsored by PolyNovo Biomaterials Pty, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05506215's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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