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

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Integra LifeSciences Corporation

Criteria

Inclusion Criteria:

1. Subject is 18 years of age or older

2. Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.

3. Subject has Diabetes Mellitus (type 1 or type 2).

4. University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².

5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Subjects < 18 years of age

2. Subject is non-diabetic

3. Subjects who present with wounds of etiology other than diabetes

4. Subject demonstrates increased signs of clinical infection

5. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.

6. University of Texas Classification greater than grade 1A

7. Diabetic plantar foot wounds measuring >4.0cm²

8. Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing

9. Subjects participating in any other trials in regards to the diabetic foot ulcer