Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
Condition: Diabetes; Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: INTEGRA™ Flowable Matrix (Collagen)
Intervention description: INTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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