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NCT01181453 · ClinicalTrials.gov registry record · Phase 3
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
A Phase 3 study, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT01181453: Completed Phase 3 study, sponsored by Organogenesis.
NCT01181453 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01181453, a Phase 3 study, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study Summary
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
Interventions
- OTHER Comparator
- DEVICE Dermagraft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 1998-12 |
| Est. Completion | 2000-03 |
| Phase | Phase 3 |
What the finished NCT01181453 record still lists
NCT01181453 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Comparator is the first listed.
NCT01181453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01181453 about?
NCT01181453 is a clinical study titled "Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers". This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients...
What is the current status of trial NCT01181453?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 1998-12. Estimated completion is 2000-03.
What interventions are being tested in trial NCT01181453?
The interventions under investigation include: Comparator (OTHER), Dermagraft (DEVICE).
Who is sponsoring clinical trial NCT01181453?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01181453's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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