Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers



Status:Completed
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:6/20/2018
Start Date:June 2009
End Date:August 2011

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A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

This study randomly assigns patients with venous leg ulcers to receive standard therapy
(compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live
human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they
heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for
three months in order to assess patients for longer term safety.


Inclusion Criteria:

- >18 years of age

- ABI > 0.80

- Three or fewer venous leg ulcers, if multiple must be separated by 2 cm

- Ultrasound demonstrates venous reflux >0.5 seconds

- Study wound present for 1-24 months

- Study wound 2-15 sq cm surface area

- Clean, granulating wound

- Patient able and willing to sign informed consent and comply with study procedures.

- Women of childbearing potential must use birth control pills, barriers or abstinence
and have a negative pregnancy test.

Exclusion Criteria:

- Wound etiology uncertain or not from venous hypertension.

- BMI>40

- Acute or chronic infectious skin disease

- Allergy or intolerance to Profore(R)

- Wound infection, cellulitis, osteomyelitis

- >2 weeks' treatment with immunosuppressive agents in recent past

- Investigational drug use within 30 days

- Severe malnutrition, drug and/or alcohol abuse

- Malignant disease unless in remission for 5 years

- History of radiation at the study site

- Other conditions that could impede wound healing

- Known history of HIV or AIDS

- Prior participation in any Dermagraft study

- Treatment with other bioengineered tissue products within 30 days

- Unable to understand the aims and objectives of the trial

- Inability to comply with study protocol

- NYHA Class III or IV CHF

- Uncontrolled diabetes mellitus

- Dorsal foot ulcer
We found this trial at
35
sites
13851 East 14th Street
San Leandro, California 94578
341
mi
from 91732
San Leandro, CA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2578
mi
from 91732
Boston, MA
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
2320
mi
from 91732
Miami, FL
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
2559
mi
from 91732
Warwick, RI
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Altamonte Springs, Florida 32701
?
mi
from 91732
Altamonte Springs, FL
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Bay Pines, Florida 33744
2121
mi
from 91732
Bay Pines, FL
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2578
mi
from 91732
Boston, MA
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160 Dental Circle
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
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455 Pinellas Street
Clearwater, Florida 33756
2116
mi
from 91732
Clearwater, FL
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Des Moines, Iowa 50314
1422
mi
from 91732
Des Moines, IA
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Erie, Pennsylvania 16544
2117
mi
from 91732
Erie, PA
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Evans, Georgia 30809
2049
mi
from 91732
Evans, GA
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7210 North Milburn Avenue
Fresno, California 93726
218
mi
from 91732
Fresno, CA
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?
mi
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Hartberg,
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Jackson, Tennessee 38305
1653
mi
from 91732
Jackson, TN
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720 West Oak Street
Kissimmee, Florida 34741
2188
mi
from 91732
Kissimmee, FL
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Las Vegas, Nevada 89119
214
mi
from 91732
Las Vegas, NV
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10535 Hospital Way
Mather, California 95665
360
mi
from 91732
Mather, CA
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Mobile, Alabama 36608
1749
mi
from 91732
Mobile, AL
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New Haven, Connecticut 06515
2486
mi
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New Haven, CT
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Phoenix, Arizona 85050
346
mi
from 91732
Phoenix, AZ
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Phoenix, Arizona 85012
343
mi
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Phoenix, AZ
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1 Medical Plaza Drive
Roseville, California 95661
370
mi
from 91732
Roseville, CA
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700 Cooper Avenue
Saginaw, Michigan 48602
1929
mi
from 91732
Saginaw, MI
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Saint George, Utah 84770
?
mi
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Saint George, UT
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3333 W Deyoung St
Saint Joseph, Missouri 64506
(618) 998-7000
Heartland Regional Medical Center Heartland Regional Medical Center is your community healthcare provider; a 98-bed...
1336
mi
from 91732
Saint Joseph, MO
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San Diego, California 92123
101
mi
from 91732
San Diego, CA
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South Miami, Florida 33143
2318
mi
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South Miami, FL
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Stockton, California 95204
326
mi
from 91732
Stockton, CA
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
2503
mi
from 91732
Stony Brook, NY
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Summit, New Jersey 07901
2414
mi
from 91732
Summit, NJ
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7301 North University Drive
Tamarac, Florida 33321
2306
mi
from 91732
Tamarac, FL
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427
mi
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Tucson, AZ
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428
mi
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Tucson, AZ
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Washington, District of Columbia 20017
2283
mi
from 91732
Washington,
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