Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352480
• Other study ID #: CM002 Gold
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 23, 2018
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Nuo Therapeutics
• Contact: Stacy Gardner
• Phone: 240-406-1816
• Email: sgardner[@]nuot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Methodist Hospital Wound Care Center	Arcadia	California
United States	Piedmont	Atlanta	Georgia
United States	Tufts Medical Center - Center for Wound Healing	Boston	Massachusetts
United States	Bristol Hospital Wound Care Center	Bristol	Connecticut
United States	The Center for Wound Healing Crozer Chester Medical Center	Chester	Pennsylvania
United States	The Center for Wound Healing at FHN	Freeport	Illinois
United States	Catskill Regional Medical Center - Wound Healing Center	Harris	New York
United States	Memorial Hermann Memorial City	Houston	Texas
United States	Memorial Hermann South East	Houston	Texas
United States	Memorial Hermann South West	Houston	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	Onslow Memorial Hospital - Wound Care and Hyperbaric Center	Jacksonville	North Carolina
United States	Memorial Hermann Katy Rehab	Katy	Texas
United States	St. Luke's Wound and Hyperbaric Center	Meridian	Idaho
United States	Orange Regional	Middletown	New York
United States	Beverly Hospital Wound and Hyperbaric Center	Montebello	California
United States	The Wound Center of Niagara	Niagara Falls	New York
United States	St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine	Pontiac	Michigan
United States	Kaweah Delta Rehabiliation Hospital	Visalia	California

Sponsors (1)

Lead Sponsor	Collaborator
Nuo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of amputations	Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.	12 weeks
Secondary	Proportion of completely healed ulcers	Proportion of patients with completely healed diabetic foot ulcers	12 weeks
Secondary	W-QOL (Quality of life with chronic wounds) score	Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks	12 weeks