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NCT00587223 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)
A Phase 3 study, sponsored by Organogenesis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT00587223 is a Phase 3 study that was terminated before completion, run by Organogenesis. The registered enrollment target is 1 participants.
The verdict
NCT00587223, a Phase 3 study, was terminated before completion, sponsored by Organogenesis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.
Interventions
- DEVICE Apligraf
- OTHER Standard dressing regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00587223
The ClinicalTrials.gov registry entry for NCT00587223 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 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 Apligraf is the first listed.
NCT00587223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00587223 about?
NCT00587223 is a clinical study titled "Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)". The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used ...
What is the current status of trial NCT00587223?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2007-12. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00587223?
The interventions under investigation include: Apligraf (DEVICE), Standard dressing regimen (OTHER).
Who is sponsoring clinical trial NCT00587223?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
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