Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcers
- Interventions
- Device: Aurix
- Registration Number
- NCT02352480
- Lead Sponsor
- Nuo Therapeutics
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 760
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aurix + UCC Aurix 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 plus usual and customary care, which can include any advanced therapeutics.
- Primary Outcome Measures
Name Time Method Time to heal 12 weeks The primary endpoint of the trial is determine the time to heal diabetic foot ulcers treated with Aurix and Standard of Care at 12 weeks. Comparison will be made with the control arm of subjects treated only with Standard of Care.
- Secondary Outcome Measures
Name Time Method Incidence of amputations 12 weeks Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Proportion of completely healed ulcers 12 weeks Proportion of patients with completely healed diabetic foot ulcers
W-QOL (Quality of life with chronic wounds) score 12 weeks Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks
Trial Locations
- Locations (20)
Bristol Hospital Wound Care Center
🇺🇸Bristol, Connecticut, United States
St. Luke's Wound and Hyperbaric Center
🇺🇸Meridian, Idaho, United States
St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
🇺🇸Pontiac, Michigan, United States
The Center for Wound Healing Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
Tufts Medical Center - Center for Wound Healing
🇺🇸Boston, Massachusetts, United States
Methodist Hospital Wound Care Center
🇺🇸Arcadia, California, United States
The Center for Wound Healing at FHN
🇺🇸Freeport, Illinois, United States
Catskill Regional Medical Center - Wound Healing Center
🇺🇸Harris, New York, United States
Orange Regional
🇺🇸Middletown, New York, United States
Onslow Memorial Hospital - Wound Care and Hyperbaric Center
🇺🇸Jacksonville, North Carolina, United States
The Center for Wound Healing Crozer Chester Medical Center
🇺🇸Chester, Pennsylvania, United States
The Wound Center of Niagara
🇺🇸Niagara Falls, New York, United States
Memorial Hermann Memorial City
🇺🇸Houston, Texas, United States
Memorial Hermann South East
🇺🇸Houston, Texas, United States
Piedmont
🇺🇸Atlanta, Georgia, United States
Beverly Hospital Wound and Hyperbaric Center
🇺🇸Montebello, California, United States
St. Mary's Wound and Hyperbaric Center
🇺🇸Huntington, West Virginia, United States
Kaweah Delta Rehabiliation Hospital
🇺🇸Visalia, California, United States
Memorial Hermann South West
🇺🇸Houston, Texas, United States
Memorial Hermann Katy Rehab
🇺🇸Katy, Texas, United States