Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
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
1 other identifier
interventional
760
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 25, 2018
January 1, 2018
3.5 years
January 28, 2015
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Incidence of amputations
12 weeks
Proportion of completely healed ulcers
12 weeks
W-QOL (Quality of life with chronic wounds) score
12 weeks
Study Arms (2)
Aurix + UCC
EXPERIMENTALSubjects 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.
Usual and Customary Care
NO INTERVENTIONSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuo Therapeuticslead
Study Sites (20)
Methodist Hospital Wound Care Center
Arcadia, California, 91007, United States
Beverly Hospital Wound and Hyperbaric Center
Montebello, California, 90640, United States
Kaweah Delta Rehabiliation Hospital
Visalia, California, 93277, United States
Bristol Hospital Wound Care Center
Bristol, Connecticut, 06410, United States
Piedmont
Atlanta, Georgia, 30309, United States
St. Luke's Wound and Hyperbaric Center
Meridian, Idaho, 86342, United States
The Center for Wound Healing at FHN
Freeport, Illinois, 61032, United States
Tufts Medical Center - Center for Wound Healing
Boston, Massachusetts, 02111, United States
St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
Pontiac, Michigan, 48341, United States
Catskill Regional Medical Center - Wound Healing Center
Harris, New York, 12742, United States
Orange Regional
Middletown, New York, 10940, United States
The Wound Center of Niagara
Niagara Falls, New York, 14301, United States
Onslow Memorial Hospital - Wound Care and Hyperbaric Center
Jacksonville, North Carolina, 28546, United States
The Center for Wound Healing Crozer Chester Medical Center
Chester, Pennsylvania, 19013, United States
Memorial Hermann Memorial City
Houston, Texas, 77024, United States
Memorial Hermann South West
Houston, Texas, 77074, United States
Memorial Hermann South East
Houston, Texas, 77089, United States
Memorial Hermann Katy Rehab
Katy, Texas, 77450, United States
St. Mary's Wound and Hyperbaric Center
Huntington, West Virginia, 25702, United States
The Center for Wound Healing Cabell Huntington Hospital
Huntington, West Virginia, 25703, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Clausen, PhD
Nuo Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share