Effectiveness of Aurix Therapy in Venous Leg Ulcers

Status unconfirmed · Not applicable

Conditions studied: Venous Leg Ulcers

In brief

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

Key facts

Study ID

NCT02352454

Run by

Nuo Therapeutics

People needed

640

Starts

2015-02-01

Expected to finish

2018-07-01

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Center for Wound Healing Cabell Huntington Hospital — Huntington, West Virginia, United States (enrolling)
• Beverly Hospital Wound and Hyperbaric Center — Montebello, California, United States (enrolling)
• Kaweah Delta Rehabiliation Hospital — Visalia, California, United States (enrolling)
• Bristol Hospital Wound Care Center — Bristol, Connecticut, United States (enrolling)
• Piedmont — Atlanta, Georgia, United States (enrolling)
• St. Luke's Wound and Hyperbaric Center — Meridian, Idaho, United States (enrolling)
• Methodist Hospital Wound Care Center — Arcadia, California, United States (enrolling)
• Tufts Medical Center - Center for Wound Healing — Boston, Massachusetts, United States (enrolling)
• St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine — Pontiac, Michigan, United States (enrolling)
• Catskill Regional Medical Center - Wound Healing Center — Harris, New York, United States (enrolling)
• Orange Regional — Middletown, New York, United States (enrolling)
• The Wound Center of Niagara — Niagara Falls, New York, United States (enrolling)
• Onslow Memorial Hospital - Wound Care and Hyperbaric Center — Jacksonville, North Carolina, United States (enrolling)
• Onslow Memorial Hospital Wound Care and Hyperbaric Center — Jacksonville, North Carolina, United States (enrolling)
• Berger Wound Healing Center — Circleville, Ohio, United States (enrolling)
• The Center for Wound Healing Crozer Chester Medical Center — Chester, Pennsylvania, United States (enrolling)
• Memorial Hermann Memorial City — Houston, Texas, United States (enrolling)
• Memorial Hermann South West — Houston, Texas, United States (enrolling)
• Memorial Hermann South East — Houston, Texas, United States (enrolling)
• Memorial Hermann Katy Rehab — Katy, Texas, United States (enrolling)
• Harrison Wound Care & Hyperbaric Medicine — Bremerton, Washington, United States (enrolling)
• St. Mary's Wound and Hyperbaric Center — Huntington, West Virginia, United States (enrolling)
• The Center for Wound Healing at FHN — Freeport, Illinois, United States

Full record on ClinicalTrials.gov

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