Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: Aurix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aurix + UCC<br>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. | Device: Aurix<br>* 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.<br>|
| No Intervention: Usual and Customary Care<br>Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week there after while receiving usual and customary care, but actual frequency of visits will be determined by the treating physician. Usual and customary care, which can include any advanced therapeutics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heal | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of amputations | Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested. | 12 weeks | 
| Proportion of completely healed ulcers | Proportion of patients with completely healed diabetic foot ulcers | 12 weeks | 
| W-QOL (Quality of life with chronic wounds) score | Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Healing Wound