VLU Dressing Study

Inclusion criteria

• Adults, 18 years old and older (i.e. age ≥ 18 years).
• Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
• If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
• If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
• Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
• Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
• VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
• VLU present for at least one month prior to screening visit 1.
• VLU at least 2 cm2 in size but not larger than 100 cm2.
• After debridement, study ulcer demonstrates a clean wound bed.
• If subject is a female of childbearing potential, subject must use at least one method of contraception acceptable by PI such as birth control pills, Intrauterine Device (IUD), condoms, or sexual abstinence. At visit 1 urine pregnancy test must be negative.
• Subject is able to comprehend all study related procedures and adhere to study schedule.
• Subject is able to provide written informed consent.

Exclusion criteria

• Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
• 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.
• Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
• Subject has known allergy to any of the materials used in the study.
• Subject is unable to tolerate multi-layer compression therapy.
• Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
• 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.
• In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.
• 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).
• Study ulcer area has been treated with radiation therapy at any time.
• 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.
• 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).
• Subject is diagnosed with New York Heart Association Class III and IV congestive heart.
• Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
• Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C >10%.
• Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus).
• 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.
• Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding.
• 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.