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Aurix Therapy in Venous Leg Ulcers
||A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers
||Geneve Allison, MD
Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLUs) will be treated using Aurix in approximately 100 sites in the US. A physician can enroll a patient in the study for Aurix treatment provided inclusion/exclusion criteria are met. Patients will receive Aurix + Usual and Customary Care (UCC) or UCC alone twice a week for the first two weeks and, then, once a week thereafter. The primary endpoint of the trial is to determine the time to heal at 12 weeks VLUs treated with Aurix + UCC versus UCC alone.
- Medicare eligible
- Proven venous disease
- Debrided ulcer size between 2-200 square cm.
- Subject known to be sensitive to Aurix components (CaCl, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by Aurix
- Ulcer not of VLU pathophysiology
Subjects will be seen in the clinic and treated with Aurix + UCC or UCC alone twice a week for the first two weeks and, then, once a week thereafter for up to 12 weeks. At each treatment visit, the subject will undergo a blood-draw.