Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
|ClinicalTrials.gov Identifier: NCT02352480|
Recruitment Status : Unknown
Verified January 2018 by Nuo Therapeutics.
Recruitment status was: Recruiting
First Posted : February 2, 2015
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Device: Aurix||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||760 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Aurix + UCC
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.
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.
No Intervention: Usual and Customary Care
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.
- Time to heal [ Time Frame: 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.
- Incidence of amputations [ Time Frame: 12 weeks ]Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
- Proportion of completely healed ulcers [ Time Frame: 12 weeks ]Proportion of patients with completely healed diabetic foot ulcers
- W-QOL (Quality of life with chronic wounds) score [ Time Frame: 12 weeks ]Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352480
|Contact: Stacy Gardnerfirstname.lastname@example.org|
|Study Director:||Peter Clausen, PhD||Nuo Therapeutics|