Effectiveness of Aurix Therapy in Venous Leg Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02940587|
Recruitment Status : Withdrawn (New record created in clinical trials due to company re-branding, and inability to list new name as the sponsor.)
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcers||Device: Aurix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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 :||February 2018|
|Estimated Study Completion Date :||February 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 ]Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940587
|United States, Idaho|
|St. Luke's Intermountain Research|
|Boise, Idaho, United States, 83702|
|Study Director:||Peter Clausen, PhD||Nuo Therapeutics|