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Aurix Therapy in Pressure Ulcers


Title A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
Therapeutic Area Pressure 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/NCT02352467

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 pressure ulcers 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 pressure ulcers treated with Aurix + UCC versus UCC alone.

Study Details

Inclusion Criteria

  • Medicare eligible
  • Ulcer of pressure/shear etiology (Stage II, III, IV)
  • Debrided ulcer size between 3-200 square cm.

Exclusion Criteria

  • Subject known to be sensitive to Aurix components (CaCl, thrombin, ascorbic acid) and/or materials of bovine origin
  • Stage I pressure ulcers
  • Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound

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.