Effectiveness of Aurix Therapy in Diabetic Foot Ulcers



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/27/2018
Start Date:January 2015
End Date:July 2018
Contact:Stacy Gardner
Email:sgardner@nuot.com
Phone:240-406-1816

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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

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

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.

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.
We found this trial at
20
sites
840 South Akers Street
Visalia, California 93277
Phone: 559-624-3944
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300 West Huntington Drive
Arcadia, California 91007
Phone: 626-898-8927
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Atlanta, Georgia 30309
Phone: 404-351-8873
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Atlanta, GA
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800 Washington Street
Boston, Massachusetts 02111
Principal Investigator: Geneve Allison, MD
Phone: 617-636-5287
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Boston, MA
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92 Bradley Street
Bristol, Connecticut 06410
Phone: 860-585-3397
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Bristol, CT
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301 West 15th Street
Chester, Pennsylvania 19013
Phone: 610-619-8400
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Chester, PA
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1036 West Stephenson Street
Freeport, Illinois 61032
Phone: 815-599-7410
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Freeport, IL
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68 Harris-Bushville Road
Harris, New York 12742
Phone: 845-794-4620
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Harris, NY
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921 Gessner Road
Houston, Texas 77024
Phone: 713-242-4325
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Houston, TX
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7600 Beechnut Street
Houston, Texas 77074
Phone: 713-456-6100
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Houston, TX
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Houston, Texas 77089
Phone: 832-658-5100
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Houston, TX
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2900 1st Ave
Huntington, West Virginia 25702
Phone: 304-399-7450
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Huntington, WV
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1340 Huntington State Hospital Road,Hal Greer Blvd
Huntington, West Virginia 25703
Phone: 304-399-3510
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Huntington, WV
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237 Old White Street
Jacksonville, North Carolina 28546
Phone: 910-577-4977
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Jacksonville, NC
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21720 Kingsland Boulevard
Katy, Texas 77450
Phone: 281-579-5542
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Katy, TX
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3277 East Louise Drive
Meridian, Idaho 86342
Principal Investigator: Warren Gude
Phone: 208-489-4326
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Meridian, ID
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707 East Main Street
Middletown, New York 10940
Principal Investigator: Inocencia Carrano
Phone: 845-333-7706
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309 W Beverly Blvd
Montebello, California 90640
Phone: 323-726-1222
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Montebello, CA
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621 10th Street
Niagara Falls, New York 14301
Phone: 716-278-4424
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44405 Woodward Avenue
Pontiac, Michigan 48341
Phone: 248-858-2606
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Pontiac, MI
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