VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: SECONDARY dressing gauze and tape; debridement, irrigation; Dermagraft; Oasis
Intervention description: SECONDARY dressing gauze and tape; debridement, irrigation; Dermagraft per company protocol; Oasis per company protocol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer; Chronic wounds; Chronic ulcers; Oasis; Dermagraft; Adaptic

Summary:

      The primary objective of this study is to assess the effectiveness of cellular dermal
      replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing
      diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

        (Answering NO will exclude patient):

          -  An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to
             any study-related activities.

          -  The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit
             3/Week 0.

          -  Subjects between 18 and 85 years of age.

          -  Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is
             greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from
             three measurements within last 6 months shall apply).or a toe-arm index is equal to or
             higher than 0.6.

          -  The patient has one or more diabetic ulcers on the target foot with only one ulcer
             selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a
             non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with
             another ulcer within 12 weeks of randomization.

          -  Subject's study ulcer is full thickness and does not extend to bone, muscle, or
             tendon.

          -  Subject's study ulcer has been present at least 4 weeks prior to the initial screening
             (Visit 1) or 6 weeks at randomization (Visit 3).

          -  Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.

          -  Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated
             bacterial load of the wound).

          -  For female subjects of childbearing age potential, the subject has a negative
             pregnancy test and is not lactating for the duration of the study.

          -  Subject understands the requirements of this study and is willing to comply with all
             the study requirements.

        Exclusion Criteria:

        (Answering YES will exclude patient):

          -  The subject is diagnosed with cancer and is undergoing treatment with
             immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids
             less than 30 days before enrollment.

          -  The subject is diagnosed with HIV/AIDS.

          -  The subject is diagnosed with any bleeding disorders.

          -  The subject is diagnosed with any connective tissue diseases.

          -  For female subjects, the subject is pregnant or lactating.

          -  The subject has a history of illicit drug use within one year of enrollment.

          -  In the past year, the subject experiences episodes of drinking more than 5 alcoholic
             beverages in less than two hours and/or drinking alcohol has become a problem in
             interpersonal relationships, work, driving and/or their behavior in general.

          -  The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy,
             MRI or bone scan).

          -  Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.

          -  The subject is diagnosed with active Charcot as described by Saunder's classification
             system.

          -  The subject manifests signs of poor nutritional status and/or albumin level < 2.9.

          -  The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.

          -  The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.

          -  The subject has any porcine allergy or cow product allergy.

          -  The subject's recent (last 30 days) chemistry tests serum creatinine is 2 times above
             the upper limit of normal and/or LFT's 3 times above the upper limit of normal.

          -  Between Visit 1/Week -2 and Visit 3/Week 0 (randomization) the study ulcer has
             decreased in size by more than 40%, or increased in size by more than 50%.