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Aurix Therapy in Diabetic Foot Ulcers


Title 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
Therapeutic Area Diabetic Foot Ulcers
Principal Investigator Geneve Allison, MD
Min Age 18 Years
Gender All
Contact Kaytie Beasley
617 636-5287
More Information https://clinicaltrials.gov/ct2/show/NCT02352480

Overview

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.

Study Details

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Study Requirements

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.