Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers

Inclusion Criteria

• •1. Male or Female, 18 years of age or older
• •2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
• •3. Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
• •4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening
• •5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
• •6. Subject has a venous leg ulcer without infection or clinically visible exposed bone
• •7. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
• •8. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
• •9. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1
• •10. Index wound is free of necrotic debris prior to Hyalomatrix application
• •11. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
• •12. Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
• •13. Subject is able and willing to follow the protocol requirements
• •14. Subject had signed informed consent
• •15. If 2 or more wounds are present, the wounds must be separated by at least 2 cm