Effectiveness of Aurix Therapy in Venous Leg Ulcers

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience
recurring ulcers after the first ulcer. While treatment of the underlying venous disease,
depending on the mode of treatment, can lower the recurrence rate in many patients, it does
not affect recurrence. 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,
measured as complete wound healing, in a prospective, randomized trial in which venous leg
ulcers will be treated using Aurix and standard of care and compared 1:1 to patients
receiving undefined Usual and Customary Care (UCC).

Inclusion Criteria:

1. Medicare eligible

2. ≥18 years of age

3. Proven venous disease

4. The largest non-healing wound, if multiple wounds are present, or the single wound to
be treated (Index Ulcer) that is located between and including the knee and the ankle

5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be
selected as Index Ulcer for study. There must be at least 4 cm between the Index Ulcer
and other ulcers; if all ulcers are closer than 4 cm, the subject should not be
enrolled (screen failure)

6. Debrided ulcer size between 2 cm2 and 200 cm2

7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic

8. Demonstrated adequate compression regimen

9. Duration ≥ 1 month at first visit

10. Subject must be willing to comply with the Protocol, which will be assessed by
enrolling clinician

Exclusion Criteria:

1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin,
ascorbic acid) and/or materials of bovine origin

2. Presence of another wound that is concurrently treated and might interfere with
treatment of index wound by Aurix

3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation,
rheumatoid, collagen vascular disease, pressure, or arterial etiology)

4. Patients on chemotherapeutic agents or any malignancy in the wound area

5. Subjects who are cognitively impaired

6. Serum albumin of less than 2.5 g/dL

7. Plasma Platelet count of less than 100 x 109/L

8. Hemoglobin of less than 10.5 g/dL

9. Subject has inadequate venous access for repeated blood draw required for Aurix
Administration.