Effectiveness of Aurix Therapy in Venous Leg Ulcers
Venous Leg Ulcers
About this trial
This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Non Healing Wound
Eligibility Criteria
Inclusion Criteria:
- Medicare eligible
- ≥18 years of age
- Proven venous disease
- 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
- 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)
- Debrided ulcer size between 2 cm2 and 200 cm2
- Subject has received UCC care for ≥ 2 weeks at treating wound clinic
- Demonstrated adequate compression regimen
- Duration ≥ 1 month at first visit
- Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician
Exclusion Criteria:
- Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
- Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
- Patients on chemotherapeutic agents or any malignancy in the wound area
- Subjects who are cognitively impaired
- Serum albumin of less than 2.5 g/dL
- Plasma Platelet count of less than 100 x 109/L
- Hemoglobin of less than 10.5 g/dL
- Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
Sites / Locations
- Methodist Hospital Wound Care CenterRecruiting
- Beverly Hospital Wound and Hyperbaric CenterRecruiting
- Kaweah Delta Rehabiliation HospitalRecruiting
- Bristol Hospital Wound Care CenterRecruiting
- PiedmontRecruiting
- St. Luke's Wound and Hyperbaric CenterRecruiting
- The Center for Wound Healing at FHN
- Tufts Medical Center - Center for Wound HealingRecruiting
- St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric MedicineRecruiting
- Catskill Regional Medical Center - Wound Healing CenterRecruiting
- Orange RegionalRecruiting
- The Wound Center of NiagaraRecruiting
- Onslow Memorial Hospital - Wound Care and Hyperbaric CenterRecruiting
- Onslow Memorial Hospital Wound Care and Hyperbaric CenterRecruiting
- Berger Wound Healing CenterRecruiting
- The Center for Wound Healing Crozer Chester Medical CenterRecruiting
- Memorial Hermann Memorial CityRecruiting
- Memorial Hermann South WestRecruiting
- Memorial Hermann South EastRecruiting
- Memorial Hermann Katy RehabRecruiting
- Harrison Wound Care & Hyperbaric MedicineRecruiting
- St. Mary's Wound and Hyperbaric CenterRecruiting
- The Center for Wound Healing Cabell Huntington HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Aurix + UCC
Usual and Customary Care
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment and usual and customary care, which can include advanced therapeutics.
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive usual and customary care, which can include advanced therapeutics.