Effectiveness of Aurix Therapy in Venous Leg Ulcers

This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Non Healing Wound Read More

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.