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NCT01108263 · ClinicalTrials.gov registry record · Phase 4
Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
A Phase 4 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT01108263 is a Phase 4 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 5 participants.
The verdict
NCT01108263, a Phase 4 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
* After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. * Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit. * Both groups will be debrided and have pictures taken in the OR * Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR. * Subjects will be placed in a total contact cast at each visit. If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
Interventions
- DRUG INTEGRA™ Flowable Matrix (Collagen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01108263
The ClinicalTrials.gov registry entry for NCT01108263 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INTEGRA™ Flowable Matrix (Collagen) is the first listed.
NCT01108263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01108263 about?
NCT01108263 is a clinical study titled "Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers". * After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. * Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will...
What is the current status of trial NCT01108263?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2010-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01108263?
The interventions under investigation include: INTEGRA™ Flowable Matrix (Collagen) (DRUG).
Who is sponsoring clinical trial NCT01108263?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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