VLU Dressing Study

Inclusion Criteria:

1. Adults, 18 years old and older (i.e. age ≥ 18 years).

2. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness butwithout exposure of deeper tissues (muscle bone or tendon).

3. If more than one ulcer is present, the largest ulcer meeting criteria shall bedesignated the study ulcer.

4. If more than one ulcer on the study ulcer limb, study ulcer shall be at least onecentimeter from other ulcers.

5. Venous Doppler ultrasound exam, within one year from randomization, shalldemonstrate reflux of over 0.5 seconds in the affected limb.

6. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb

7. VLU has been treated with silver based therapy for at least 2 weeks within theprevious 6 months.

8. VLU present for at least one month prior to screening visit 1.

9. VLU at least 2 cm2 in size but not larger than 100 cm2.

10. After debridement, study ulcer demonstrates a clean wound bed.

11. If subject is a female of childbearing potential, subject must use at least onemethod of contraception acceptable by PI such as birth control pills, IntrauterineDevice (IUD), condoms, or sexual abstinence. At visit 1 urine pregnancy test must benegative.

12. Subject is able to comprehend all study related procedures and adhere to studyschedule.

13. Subject is able to provide written informed consent.

Exclusion Criteria:

1. Based on investigator medical judgment, ulcer is caused by any etiology exclusive ofvenous 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 betweenscreening 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 systemicimmunosuppressive medications for more than 2 weeks (e.g. chemotherapy,corticosteroids), and/or it is anticipated subject will require such medicationsduring study period.

8. In the month prior to screening visit 1 subject was enrolled in any other researchprotocol for treatment of Study Ulcer.

9. The Subject has been diagnosed with malignant disease not in remission over the 5years immediately preceding screening visit 1. (Except: cervical carcinoma in situ,cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have beentreated 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 forparticipation in study.

12. In the month preceding screening visit 1 Study Ulcer has been treated with advancedtissue engineered devices matrix based devices (e.g., Apligraf, Dermagraft, Oasis).

13. Subject is diagnosed with New York Heart Association Class III and IV congestiveheart.

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 bedefined 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 onemethod 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 potentialor active pregnancy or breast-feeding.

19. In the opinion of the PI the subject is unable to understand or comply with studyrelated protocol including but not limited to providing informed consent.