Effectiveness of Aurix Therapy in Venous Leg Ulcers
|ClinicalTrials.gov Identifier: NCT02352454|
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|
|Venous Leg Ulcers||Device: Aurix||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 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 Venous Leg Ulcers|
|Study Start Date :||February 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 and usual and customary care, which can include advanced therapeutics.
Aurix is a platelet-rich plasma gel used in the treatment of non-healing 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 thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive usual and customary care, which can include advanced therapeutics.
- Time to Heal [ Time Frame: 12 weeks ]Aurix plus standard of care versus usual and customary care only. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds ─ Developing Products for Treatment, 2006).
- Proportion of wounds healed [ Time Frame: 12 weeks ]Comparison of proportion of wounds healed over 12 weeks
- Change in Quality of Life with Chronic Wounds (W-QOL) Score [ Time Frame: 12 weeks ]Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352454
|Contact: Stacy Gardnerfirstname.lastname@example.org|
|Study Director:||Peter Clausen, PhD||Nuo Therapeutics|