Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
NCT ID: NCT00909870
Last Updated: 2018-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
537 participants
INTERVENTIONAL
2009-06-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Dermagraft(R)
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
2
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Profore
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Interventions
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Dermagraft(R)
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Profore
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Organogenesis
INDUSTRY
Responsible Party
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Principal Investigators
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William Marston, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina School of Medicine, Chapel Hill, NC
Keith Harding, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiff University School of Medicine, Wales, UK
David Bergqvist, MD
Role: PRINCIPAL_INVESTIGATOR
University of Uppsala, Sweden
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Dr. Jagpreet S. Mukker
Fresno, California, United States
VA Northern California Health Care System
Mather, California, United States
Sutter Roseville Medical Center Wound Care Center
Roseville, California, United States
Therapeutics Clinical Research
San Diego, California, United States
General Vascular Surgery Group
San Leandro, California, United States
Pacific Wound Center
Stockton, California, United States
North American Center for Limb Preservation
New Haven, Connecticut, United States
Providence Hospital
Washington D.C., District of Columbia, United States
Foot & Ankle Associates of Florida
Altamonte Springs, Florida, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Comprehensive Wound Healing Center
Clearwater, Florida, United States
Osceola Regional Wound Care Center
Kissimmee, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Doctor's Research Network
South Miami, Florida, United States
Robert Snyder, DPM, CWS
Tamarac, Florida, United States
Aiyan Diabetes Center
Evans, Georgia, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
Boston Medical Center, Department of Vascular Surgery
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Covenant Wound Healing Center
Saginaw, Michigan, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
Overlook Hospital Wound Healing Program
Summit, New Jersey, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
University of North Carolina Division of Vascular Surgery
Chapel Hill, North Carolina, United States
Saint Vincent Health Center
Erie, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Jackson Madison County General Hospital
Jackson, Tennessee, United States
Dixie Regional Meidcal Center
St. George, Utah, United States
Private Practice FA fur Dermatologie Clinical Centre
Hartberg, , Austria
Private Practice / Clinical Centre
Vienna, , Austria
East-Tallinn Central Hospital
Tallinn, , Estonia
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg im Breisgau, , Germany
Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, , Germany
Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
Gdynia, , Poland
AKMed Medical Centre
Krakow, , Poland
NZOZ Clinical for Vascular Diseases
Krakow, , Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
5 Wojskowy Szpital Kliniczny w Krakowie
Krakow, , Poland
S. Zeromski Hospital Krakow
Krakow, , Poland
NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
Lodz, , Poland
Clinical Trials Centre
Lublin, , Poland
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sącz, , Poland
"Medyk" Medical Center
Rzeszów, , Poland
General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
Warsaw, , Poland
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
Wroclaw, , Poland
Langeberg Medical Centre
Kraaifontein, Cape Town, South Africa
Worthwhile Clinical Trials Lakeview Hospital
Benoni, Johannesburg, South Africa
Edenvale Hospital, c/o CEO Secretary
Edenvale, Johhanesburg, South Africa
GCT-Mercantile Clinical Trial Centre
Korsten, Port Elizabeth, South Africa
Synexus SA Watermeyer Clinical Research Centre
Meyerspark, Pretoria, South Africa
Josha Research
Bloemfontein, , South Africa
Dr. D.R.Lakha, Private Practice
Johannesburg, , South Africa
I Engelbrecht Research
Lyttelton, , South Africa
Middelburg Hospital
Middelburg, , South Africa
Uncedo Clinical Research Services Mercantile Hospital
Port Elizabeth, , South Africa
Cachetmed Medical Centre
Potchefstroom, , South Africa
Randles Road Medical Centre
Sydenham, Durban, , South Africa
Clinical Projects Research SA
Worcester, , South Africa
University of Lund Dept of Dermatology
Lund, , Sweden
Overlakare/Klinikchef Hud Kliniken
Stockholm, , Sweden
Wound Clinic on Fairfield
Croydon, Surrey, United Kingdom
Bradford Hospitals NHS Trust
Bradford, , United Kingdom
Cardiff University
Cardiff, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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Other Identifiers
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ABH-Dermagraft-001-08
Identifier Type: -
Identifier Source: org_study_id
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