Use of INTEGRAâ„¢ 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 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.