VLU Dressing Study

Exclusion Criteria

• •1. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
• •2. Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit 1.
• •3. Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
• •4. Subject has known allergy to any of the materials used in the study.
• •5. Subject is unable to tolerate multi-layer compression therapy.
• •6. Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
• •7. In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period.
• •8. In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.
• •9. The Subject has been diagnosed with malignant disease not in remission over the 5 years immediately preceding screening visit 1. (Except: cervical carcinoma in situ, cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have been treated and have no evidence of recurrence or metastases).
• •10. Study ulcer area has been treated with radiation therapy at any time.
• •11. In the opinion of PI the subject has a medical condition such as autoimmune, renal, hepatic or hematologic disease that makes the subject an inappropriate candidate for participation in study.
• •12. In the month preceding screening visit 1 Study Ulcer has been treated with advanced tissue engineered devices matrix based devices (e.g., Apligraf, Dermagraft, Oasis).
• •13. Subject is diagnosed with New York Heart Association Class III and IV congestive heart.
• •14. Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
• •15. Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C \>10%.
• •16. Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus).
• •17. Subject is a female of childbearing potential, and refusing to use at least one method of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual abstinence.
• •18. Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding.
• •19. In the opinion of the PI the subject is unable to understand or comply with study related protocol including but not limited to providing informed consent.