Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
760 participants
INTERVENTIONAL
2015-01-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
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.
No interventions assigned to this group
Interventions
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Aurix
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
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Inclusion Criteria
2. ≥18 years of age
3. Type I or II diabetes requiring medical treatment as determined by the physician
4. 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)
5. 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)
6. Debrided ulcer size between 0.5 cm2 and 50 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate offloading regimen
9. Duration ≥ 1 month at first visit
10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
Exclusion Criteria
2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by Aurix
3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Patients on chemotherapeutic agents or any malignancy in the wound area
5. Subjects who are cognitively impaired
6. Serum albumin of less than 2.5 g/dL
7. Plasma Platelet count of less than 100 x 109/L
8. Hemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for Aurix administration.
18 Years
ALL
No
Sponsors
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Nuo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Clausen, PhD
Role: STUDY_DIRECTOR
Nuo Therapeutics
Locations
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Methodist Hospital Wound Care Center
Arcadia, California, United States
Beverly Hospital Wound and Hyperbaric Center
Montebello, California, United States
Kaweah Delta Rehabiliation Hospital
Visalia, California, United States
Bristol Hospital Wound Care Center
Bristol, Connecticut, United States
Piedmont
Atlanta, Georgia, United States
St. Luke's Wound and Hyperbaric Center
Meridian, Idaho, United States
The Center for Wound Healing at FHN
Freeport, Illinois, United States
Tufts Medical Center - Center for Wound Healing
Boston, Massachusetts, United States
St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
Pontiac, Michigan, United States
Catskill Regional Medical Center - Wound Healing Center
Harris, New York, United States
Orange Regional
Middletown, New York, United States
The Wound Center of Niagara
Niagara Falls, New York, United States
Onslow Memorial Hospital - Wound Care and Hyperbaric Center
Jacksonville, North Carolina, United States
The Center for Wound Healing Crozer Chester Medical Center
Chester, Pennsylvania, United States
Memorial Hermann Memorial City
Houston, Texas, United States
Memorial Hermann South West
Houston, Texas, United States
Memorial Hermann South East
Houston, Texas, United States
Memorial Hermann Katy Rehab
Katy, Texas, United States
St. Mary's Wound and Hyperbaric Center
Huntington, West Virginia, United States
The Center for Wound Healing Cabell Huntington Hospital
Huntington, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Anne Villarama
Role: primary
Omar Sabha
Role: primary
Ronald Devine, MD
Role: primary
Teri Biven
Role: backup
Victoria Cardwell, RN
Role: primary
Cassandra Laflair, RN
Role: primary
Sabrina Briggs, RN
Role: primary
Brandi Dillon, RN
Role: primary
Other Identifiers
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CM002 Gold
Identifier Type: -
Identifier Source: org_study_id
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