Clinical trial NCT02352480: Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Non Healing Wound
Lead sponsor: Nuo Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of Aurix have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the of complete wound healing in a prospective, open-label, randomized trial in which diabetic foot ulcers will be treated using Aurix to determine the time to heal at 12 weeks. Comparison will be made on a 1:1 basis of Aurix + UCC versus control subjects receiving undefined UCC.

Eligibility criteria: Inclusion Criteria:

1. Medicare eligible
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:

1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
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.

Primary outcomes:
measure: Time to heal
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of amputations
timeFrame: 12 weeks
measure: Proportion of completely healed ulcers
timeFrame: 12 weeks
measure: W-QOL (Quality of life with chronic wounds) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Methodist Hospital Wound Care Center
state: California
city: Montebello
country: United States
facility: Beverly Hospital Wound and Hyperbaric Center
state: California
city: Visalia
country: United States
facility: Kaweah Delta Rehabiliation Hospital
state: California
city: Bristol
country: United States
facility: Bristol Hospital Wound Care Center
state: Connecticut
city: Atlanta
country: United States
facility: Piedmont
state: Georgia
city: Meridian
country: United States
facility: St. Luke's Wound and Hyperbaric Center
state: Idaho
city: Freeport
country: United States
facility: The Center for Wound Healing at FHN
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center - Center for Wound Healing
state: Massachusetts
city: Pontiac
country: United States
facility: St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
state: Michigan
city: Harris
country: United States
facility: Catskill Regional Medical Center - Wound Healing Center
state: New York
city: Middletown
country: United States
facility: Orange Regional
state: New York
city: Niagara Falls
country: United States
facility: The Wound Center of Niagara
state: New York
city: Jacksonville
country: United States
facility: Onslow Memorial Hospital - Wound Care and Hyperbaric Center
state: North Carolina
city: Chester
country: United States
facility: The Center for Wound Healing Crozer Chester Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann Memorial City
state: Texas
city: Houston
country: United States
facility: Memorial Hermann South West
state: Texas
city: Houston
country: United States
facility: Memorial Hermann South East
state: Texas
city: Katy
country: United States
facility: Memorial Hermann Katy Rehab
state: Texas
city: Huntington
country: United States
facility: St. Mary's Wound and Hyperbaric Center
state: West Virginia
city: Huntington
country: United States
facility: The Center for Wound Healing Cabell Huntington Hospital
state: West Virginia
Study officials:
affiliation: Nuo Therapeutics
name: Peter Clausen, PhD
role: STUDY_DIRECTOR
References: