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NCT05417425 · ClinicalTrials.gov registry record · Phase 1
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
A Phase 1 study, sponsored by Omeza.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT05417425: Completed Phase 1 study, sponsored by Omeza.
NCT05417425 is a Phase 1 study that has completed, run by Omeza. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417425, a Phase 1 study, has completed, sponsored by Omeza.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
Primary Outcome
After a 2 week screening phase with standard of care and total contact casting, the wound will be measured and assessed by Tissue Analytics platform. At each treatment visit the change in the wound size and healing status will be assessed. After 4 weeks of treatment the change in wound size will be compared to baseline measurement from treatment visit 1 and the percent area reduction (PAR) recorded.
Interventions
- COMBINATION_PRODUCT Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
What the finished NCT05417425 record still lists
NCT05417425 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant is the first listed.
NCT05417425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05417425 about?
NCT05417425 is a clinical study titled "Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers". This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
What is the current status of trial NCT05417425?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-09-01. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05417425?
The interventions under investigation include: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05417425?
This trial is sponsored by Omeza, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05417425's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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