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

Diabetes Clinical Trial

Official title: The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Foot Ulcer
• Ulcer

• NCT number: NCT01108263
• Study type: Interventional
• Source: Georgetown University
• Status: Terminated
• Phase: Phase 4
• Start date: June 2010
• Completion date: August 2011