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NCT01596920 · ClinicalTrials.gov registry record · Phase 4
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
A Phase 4 study, sponsored by Osiris Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT01596920 is a Phase 4 study that has completed, run by Osiris Therapeutics. The registered enrollment target is 97 participants.
The verdict
NCT01596920, a Phase 4 study, has completed, sponsored by Osiris Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator. Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.
Interventions
- OTHER Control
- OTHER Tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01596920
The ClinicalTrials.gov registry entry for NCT01596920 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Osiris Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01596920 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01596920 about?
NCT01596920 is a clinical study titled "Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers". The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 10...
What is the current status of trial NCT01596920?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2012-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01596920?
The interventions under investigation include: Control (OTHER), Tissue (OTHER).
Who is sponsoring clinical trial NCT01596920?
This trial is sponsored by Osiris Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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