Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment
Condition: Diabetes Type I; Diabetes Type II
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: DermGEN
Intervention description: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Diabetic type I/II patients with chronic ulcer present
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic; Chronic Ulcer; Wound Healing; Leg

Summary:

      The purpose of this clinical trial is to perform a limited pilot study to determine the
      safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU).
      This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will
      result in positive healing outcomes with no significant adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject will be considered eligible to participate in this study if each of the following
        inclusion criteria is satisfied:

          1. Patient with documented stable Type I or II diabetes (HbA1C >7.0 within 1 month prior
             to Day 0).

          2. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.

          3. Study ulcer has healed <30% in size during the 2 weeks prior to Day 0.

          4. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.

          5. Ulcer extends through dermis and into subcutaneous tissue but without exposure of
             muscle, tendon, bone or joint capsule.

          6. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy
             vascular tissue suitable for skin grafting on Day 0.

          7. Patient has adequate circulation to the foot as evidenced by palpable pulse or pulse
             detectable with Doppler ultrasound, and lack of visible cyanosis in skin bordering the
             ulcer.

          8. Female patients are not pregnant at time of, or during study.

          9. Patient and caregiver ready and willing to participate and comply with follow-up
             regime.

         10. Patient or legal representative has read and signed the Institutional Ethics Review
             Board approved informed consent form.

        Exclusion Criteria:

        A subject will not be considered eligible to participate in this study if any one of the
        following exclusion criteria is satisfied:

          1. Evidence of gangrene on affected foot.

          2. Ulcer is over Charcot deformity (fractures or dislocation).

          3. Ulcer is non-diabetic in etiology.

          4. Ulcer has tunnels or sinus tracts that cannot be completely debrided.

          5. Medical condition(s) that in the Investigator's opinion make the patient inappropriate
             for study

          6. Patient has/had malignant disease not in remission for 5 years or more

          7. Patient has acute or chronic hepatitis, cirrhosis, serum albumin <2.0 gm/dL, or has
             alkaline phosphatase or LDH at twice the normal upper limit

          8. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic
             agents, or is anticipated to require such agents during study

          9. Patient received radiation therapy within 30 days of Day 0 of study

         10. Patient has AIDS or is infected with HIV

         11. Patient has participated in another study using investigational drug(s) or device
             within the previous 30 days

         12. Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis

         13. Patient has any other condition which seriously compromises their ability to complete
             the study

         14. Patient has known allergies to antibiotics, such as penicillin and streptomycin

         15. Patient has a history of bleeding disorder

         16. Patient received elective osseous procedures to the study foot within 30 days prior to
             screening visit, except that patients whose DFU overlies an area of treated
             osteomyelitis may be included, providing there exists a suitable base for application
             of the DermGEN.