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Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers

2014-08-27 03:14:26 | BioPortfolio

Summary

- After determining if subjects meet the criteria to be included in the study, the wound will be debrided (cleansed of any dead tissue or infection).

- Subjects will then be randomly placed in either Group 1 or 2.

- The INTEGRA™ Flowable Matrix will be placed on the wound, at the first visit in both groups.

- In Group 2, INTEGRA™ Flowable Matrix will also be injected deep to the wound.

- 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.

- 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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes

Intervention

INTEGRA™ Flowable Matrix (Collagen)

Location

Georgetown University Hospital
Washington, D.C
District of Columbia
United States
20007

Status

Recruiting

Source

Georgetown University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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