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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 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 281 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01181440
The ClinicalTrials.gov registry entry for NCT01181440 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 281 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 Dermagraft(R) is the first listed.
NCT01181440 reports 0 study locations.
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.
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