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

Stopped early · Phase 4

Conditions studied: Diabetes, Foot Ulcer

In brief

* 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.

Key facts

Study ID

NCT01108263

Run by

Georgetown University

People needed

5

Starts

2010-06-01

Expected to finish

2011-08-01

Last updated by the study team

2014-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years of age or older
• Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.
• Subject has Diabetes Mellitus (type 1 or type 2).
• University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².
• Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

You may not qualify if…

• Subjects < 18 years of age
• Subject is non-diabetic
• Subjects who present with wounds of etiology other than diabetes
• Subject demonstrates increased signs of clinical infection
• 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.
• University of Texas Classification greater than grade 1A
• Diabetic plantar foot wounds measuring >4.0cm²
• Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing
• Subjects participating in any other trials in regards to the diabetic foot ulcer

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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