Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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.