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Aurix Therapy in Diabetic Foot Ulcers
||A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers
Diabetic Foot 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 diabetic foot ulcers (DFUs) 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 DFUs treated with Aurix + UCC versus UCC alone.
- Medicare eligible
- Type I or II diabetes requiring medical treatment as determined by the physician.
- The largest non-healing wound, if multiple wounds present, or the single wound to be treated (index ulcer) that is a Wagner 1-5 DFU that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
- 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 DFU 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.