Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
- Conditions
- Venous Leg Ulcer
- Interventions
- Device: Dermagraft(R)Device: Profore
- Registration Number
- NCT00909870
- Lead Sponsor
- Organogenesis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 537
- >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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Dermagraft(R) Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. 2 Profore Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
- Primary Outcome Measures
Name Time Method Complete Healing of the Study Ulcer by Week 16. 16 weeks
- Secondary Outcome Measures
Name Time Method Time-to-Complete Healing From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days. Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Trial Locations
- Locations (70)
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Sutter Roseville Medical Center Wound Care Center
🇺🇸Roseville, California, United States
VA Northern California Health Care System
🇺🇸Mather, California, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Saint Vincent Health Center
🇺🇸Erie, Pennsylvania, United States
Doctor's Research Network
🇺🇸South Miami, Florida, United States
Comprehensive Wound Healing Center
🇺🇸Clearwater, Florida, United States
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
GCT-Mercantile Clinical Trial Centre
🇿🇦Korsten, Port Elizabeth, South Africa
Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States
Dr. Jagpreet S. Mukker
🇺🇸Fresno, California, United States
Osceola Regional Wound Care Center
🇺🇸Kissimmee, Florida, United States
Pacific Wound Center
🇺🇸Stockton, California, United States
Foot & Ankle Associates of Florida
🇺🇸Altamonte Springs, Florida, United States
University of North Carolina Division of Vascular Surgery
🇺🇸Chapel Hill, North Carolina, United States
Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
🇩🇪Hamburg, Germany
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
🇩🇪Freiburg, Germany
Overlakare/Klinikchef Hud Kliniken
🇸🇪Stockholm, Sweden
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
Cachetmed Medical Centre
🇿🇦Potchefstroom, South Africa
Randles Road Medical Centre
🇿🇦Sydenham, Durban, South Africa
Aiyan Diabetes Center
🇺🇸Evans, Georgia, United States
University of Lund Dept of Dermatology
🇸🇪Lund, Sweden
Covenant Wound Healing Center
🇺🇸Saginaw, Michigan, United States
Dixie Regional Meidcal Center
🇺🇸Saint George, Utah, United States
Synexus SA Watermeyer Clinical Research Centre
🇿🇦Meyerspark, Pretoria, South Africa
I Engelbrecht Research
🇿🇦Lyttelton, South Africa
Dr. D.R.Lakha, Private Practice
🇿🇦Johannesburg, South Africa
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
🇵🇱Nowy Sacz, Poland
Bradford Hospitals NHS Trust
🇬🇧Bradford, United Kingdom
Cardiff University
🇬🇧Cardiff, United Kingdom
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
Uncedo Clinical Research Services Mercantile Hospital
🇿🇦Port Elizabeth, South Africa
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
General Vascular Surgery Group
🇺🇸San Leandro, California, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Josha Research
🇿🇦Bloemfontein, South Africa
Carl T. Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
North American Center for Limb Preservation
🇺🇸New Haven, Connecticut, United States
Private Practice FA fur Dermatologie Clinical Centre
🇦🇹Hartberg, Austria
5 Wojskowy Szpital Kliniczny w Krakowie
🇵🇱Krakow, Poland
NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
🇵🇱Lodz, Poland
General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
🇵🇱Warszawa, Poland
East-Tallinn Central Hospital
🇪🇪Tallinn, Estonia
NZOZ Clinical for Vascular Diseases
🇵🇱Krakow, Poland
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
🇵🇱Wroclaw, Poland
Advanced Foot & Ankle Center
🇺🇸Las Vegas, Nevada, United States
Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
🇵🇱Gdynia, Poland
"Medyk" Medical Center
🇵🇱Rzeszow, Poland
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Southern Arizona VA Health Care System (SAVAHCS)
🇺🇸Tucson, Arizona, United States
Private Practice / Clinical Centre
🇦🇹Vienna, Austria
Clinical Trials Centre
🇵🇱Lublin, Poland
Jackson Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
AKMed Medical Centre
🇵🇱Krakow, Poland
S. Zeromski Hospital Krakow
🇵🇱Krakow, Poland
Wound Clinic on Fairfield
🇬🇧Croydon, Surrey, United Kingdom
Clinical Projects Research SA
🇿🇦Worcester, South Africa
Middelburg Hospital
🇿🇦Middelburg, South Africa
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Robert Snyder, DPM, CWS
🇺🇸Tamarac, Florida, United States
Boston Medical Center, Department of Vascular Surgery
🇺🇸Boston, Massachusetts, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Providence Hospital
🇺🇸Washington, District of Columbia, United States
Overlook Hospital Wound Healing Program
🇺🇸Summit, New Jersey, United States
Charing Cross Hospital
🇬🇧London, United Kingdom