Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds.
Prospective observational studies of the effectiveness of Aurix have demonstrated promising
results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The
aim of this trial is to demonstrate the of complete wound healing in a prospective,
open-label, randomized trial in which diabetic foot ulcers will be treated using Aurix to
determine the time to heal at 12 weeks. Comparison will be made on a 1:1 basis of Aurix + UCC
versus control subjects receiving undefined UCC.

Inclusion Criteria:

1. Medicare eligible

2. ≥18 years of age

3. Type I or II diabetes requiring medical treatment as determined by the physician

4. The largest non-healing wound, if multiple wounds are present, or the single wound to
be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner
Classification) that is located on the dorsal, plantar, medial, or lateral aspect of
the foot or heel (including all toe surfaces)

5. For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 cm2

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

8. Demonstrated adequate offloading 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 the index wound by Aurix

3. Ulcer not of DFU pathophysiology (e.g., venous, 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.