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

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

• 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.

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