Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

Status unconfirmed · Not applicable

Conditions studied: Diabetic Foot 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 diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers

Key facts

Study ID

NCT02352480

Run by

Nuo Therapeutics

People needed

760

Starts

2015-01-01

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
• Type I or II diabetes requiring medical treatment as determined by the physician
• 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)
• 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)
• Debrided ulcer size between 0.5 cm2 and 50 cm2
• Subject has received UCC care for ≥ 2 weeks at treating wound clinic
• Demonstrated adequate offloading 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 the index wound by Aurix
• Ulcer not of DFU pathophysiology (e.g., venous, 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

• Methodist Hospital Wound Care Center — Arcadia, California, 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)
• The Center for Wound Healing at FHN — Freeport, Illinois, 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)
• 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)
• St. Mary's Wound and Hyperbaric Center — Huntington, West Virginia, United States (enrolling)
• The Center for Wound Healing Cabell Huntington Hospital — Huntington, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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