Effectiveness of Aurix Therapy in Pressure Ulcers

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term
acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the
treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs
have been promising. 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 and standard of care to determine time to heal at 16 weeks. Comparison
will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.

Inclusion Criteria:

1. Medicare eligible

2. ≥18 years of age

3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage
definitions)

4. The largest non-healing wound, if multiple wounds are present, or the single wound to
be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter

5. For subjects with potentially multiple eligible PUs, the largest ulcer will be
selected as the 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 3 cm2 and 200 cm2

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

8. Demonstrated adequate pressure relief 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. Stage I pressure ulcers

3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an
open wound

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

5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation,
rheumatoid, collagen vascular disease, venous, or arterial etiology)

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

7. Subjects who are cognitively impaired

8. Serum albumin of less than 2.5 g/dL

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

10. Hemoglobin of less than 10.5 g/dL

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

12. Life expectancy of < 6 months.