Effectiveness of Aurix Therapy in Pressure Ulcers



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Gastrointestinal
Therapuetic Areas:Dermatology / Plastic Surgery, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/27/2018
Start Date:February 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 Stage II-IV Pressure Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a
prospective, open-label, randomized trial in which pressure ulcers will be treated using
Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary
Care.

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term
acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the
treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs
have been promising. The aim of this trial is to demonstrate the effectiveness of complete
wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be
treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison
will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.

Inclusion Criteria:

1. Medicare eligible

2. ≥18 years of age

3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage
definitions)

4. The largest non-healing wound, if multiple wounds are present, or the single wound to
be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter

5. For subjects with potentially multiple eligible PUs, 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 3 cm2 and 200 cm2

7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic

8. Demonstrated adequate pressure relief 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. Stage I pressure ulcers

3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an
open wound

4. Presence of another wound that is concurrently treated and might interfere with
treatment of index wound by Aurix

5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation,
rheumatoid, collagen vascular disease, venous, or arterial etiology)

6. Patients on chemotherapeutic agents or any malignancy in the wound area

7. Subjects who are cognitively impaired

8. Serum albumin of less than 2.5 g/dL

9. Plasma Platelet count of less than 100 x 109/L

10. Hemoglobin of less than 10.5 g/dL

11. Subject has inadequate venous access for repeated blood draw required for Aurix
Administration.

12. Life expectancy of < 6 months.
We found this trial at
22
sites
301 West 15th Street
Chester, Pennsylvania 19013
Phone: 610-619-8400
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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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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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Langhorne, Pennsylvania 19047
Phone: 215-949-5030
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Langhorne, PA
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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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5000 Frankford Avenue
Philadelphia, Pennsylvania 19124
Phone: 267-587-9533
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Philadelphia, PA
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44405 Woodward Avenue
Pontiac, Michigan 48341
Phone: 248-858-2606
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Pontiac, MI
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840 South Akers Street
Visalia, California 93277
Phone: 559-624-3944
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Visalia, CA
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