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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 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 314 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01181453
The ClinicalTrials.gov registry entry for NCT01181453 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Organogenesis, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Comparator is the first listed.
NCT01181453 reports 0 study locations.
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.
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