Diabetic Foot Ulcers
Conditions
Keywords
Non Healing Wound
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.
Interventions
DEVICEAurix
Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
Sponsors
Nuo Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Medicare eligible 2. ≥18 years of age 3. Type I or II diabetes requiring medical treatment as determined by the physician 4. 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) 5. 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) 6. Debrided ulcer size between 0.5 cm2 and 50 cm2 7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic 8. Demonstrated adequate offloading 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 the index wound by Aurix 3. Ulcer not of DFU pathophysiology (e.g., venous, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactStacy Gardner
Outcome results
None listed