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NCT01181440 · ClinicalTrials.gov registry record · Phase 3
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
A Phase 3 study, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT01181440: Completed Phase 3 study, sponsored by Organogenesis.
NCT01181440 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 281 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01181440, a Phase 3 study, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.
Interventions
- DEVICE Dermagraft(R)
- OTHER Conventional care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 1994-09 |
| Est. Completion | 1997-01 |
| Phase | Phase 3 |
What the finished NCT01181440 record still lists
NCT01181440 is an interventional study that assigns participants to a tested intervention. The registered 281 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Dermagraft(R) is the first listed.
NCT01181440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01181440 about?
NCT01181440 is a clinical study titled "Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers". This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fib...
What is the current status of trial NCT01181440?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 1994-09. Estimated completion is 1997-01.
What interventions are being tested in trial NCT01181440?
The interventions under investigation include: Dermagraft(R) (DEVICE), Conventional care (OTHER).
Who is sponsoring clinical trial NCT01181440?
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 NCT01181440's enrollment target sits among peer trials
281 1194th of 2000 higher than 806 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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