Effect of Hyaluronic Acid ECM on Venous Ulcers

Inclusion Criteria: 1. Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months 2. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages 3. Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period. Exclusion Criteria: 1. Ulcers of non-venous etiology 2. Subject has a known sensitivity to hyaluronic acid 3. Presence of wound infection as determined by clinical signs and symptoms 4. Subject has any evidence of peripheral arterial disease (PAD) 5. Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date. 6. Pregnancy or lactation at time of treatment. 7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization. 8. Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial. 9. History of alcohol or drug abuse. 10. Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.