Clinical trial NCT00909870: Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Leg Ulcer
Keywords: Venous leg ulcer
randomized trial
clinical trial
Dermagraft
compression therapy
surgical debridement
venous stasis
chronic ulcer
chronic wound
fibroblasts
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Healing of the Study Ulcer by Week 16.
timeFrame: 16 weeks
Secondary outcomes:
measure: Time-to-Complete Healing
timeFrame: 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.
Other outcomes:
measure: Complete Healing by Week 16: Ulcers <= 12 Months Duration
timeFrame: 16 weeks
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System (SAVAHCS)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
city: Fresno
country: United States
facility: Dr. Jagpreet S. Mukker
state: California
city: Mather
country: United States
facility: VA Northern California Health Care System
state: California
city: Roseville
country: United States
facility: Sutter Roseville Medical Center Wound Care Center
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Leandro
country: United States
facility: General Vascular Surgery Group
state: California
city: Stockton
country: United States
facility: Pacific Wound Center
state: California
city: New Haven
country: United States
facility: North American Center for Limb Preservation
state: Connecticut
city: Washington
country: United States
facility: Providence Hospital
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Foot & Ankle Associates of Florida
state: Florida
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Clearwater
country: United States
facility: Comprehensive Wound Healing Center
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Wound Care Center
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: South Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Tamarac
country: United States
facility: Robert Snyder, DPM, CWS
state: Florida
city: Evans
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Des Moines
country: United States
facility: Broadlawns Medical Center
state: Iowa
city: Boston
country: United States
facility: Boston Medical Center, Department of Vascular Surgery
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saginaw
country: United States
facility: Covenant Wound Healing Center
state: Michigan
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Summit
country: United States
facility: Overlook Hospital Wound Healing Program
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Division of Vascular Surgery
state: North Carolina
city: Erie
country: United States
facility: Saint Vincent Health Center
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Saint George
country: United States
facility: Dixie Regional Meidcal Center
state: Utah
city: Hartberg
country: Austria
facility: Private Practice FA fur Dermatologie Clinical Centre
city: Vienna
country: Austria
facility: Private Practice / Clinical Centre
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital
city: Freiburg
country: Germany
facility: Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
city: Hamburg
country: Germany
facility: Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
city: Gdynia
country: Poland
facility: Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
city: Krakow
country: Poland
facility: AKMed Medical Centre
city: Krakow
country: Poland
facility: NZOZ Clinical for Vascular Diseases
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Krakow
country: Poland
facility: 5 Wojskowy Szpital Kliniczny w Krakowie
city: Krakow
country: Poland
facility: S. Zeromski Hospital Krakow
city: Lodz
country: Poland
facility: NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
city: Lublin
country: Poland
facility: Clinical Trials Centre
city: Nowy Sacz
country: Poland
facility: "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
city: Rzeszow
country: Poland
facility: "Medyk" Medical Center
city: Warszawa
country: Poland
facility: General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
city: Wroclaw
country: Poland
facility: NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
city: Kraaifontein
country: South Africa
facility: Langeberg Medical Centre
state: Cape Town
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials Lakeview Hospital
state: Johannesburg
city: Edenvale
country: South Africa
facility: Edenvale Hospital, c/o CEO Secretary
state: Johhanesburg
city: Korsten
country: South Africa
facility: GCT-Mercantile Clinical Trial Centre
state: Port Elizabeth
city: Meyerspark
country: South Africa
facility: Synexus SA Watermeyer Clinical Research Centre
state: Pretoria
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Johannesburg
country: South Africa
facility: Dr. D.R.Lakha, Private Practice
city: Lyttelton
country: South Africa
facility: I Engelbrecht Research
city: Middelburg
country: South Africa
facility: Middelburg Hospital
city: Port Elizabeth
country: South Africa
facility: Uncedo Clinical Research Services Mercantile Hospital
city: Potchefstroom
country: South Africa
facility: Cachetmed Medical Centre
city: Sydenham, Durban
country: South Africa
facility: Randles Road Medical Centre
city: Worcester
country: South Africa
facility: Clinical Projects Research SA
city: Lund
country: Sweden
facility: University of Lund Dept of Dermatology
city: Stockholm
country: Sweden
facility: Overlakare/Klinikchef Hud Kliniken
city: Croydon
country: United Kingdom
facility: Wound Clinic on Fairfield
state: Surrey
city: Bradford
country: United Kingdom
facility: Bradford Hospitals NHS Trust
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: University of North Carolina School of Medicine, Chapel Hill, NC
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University School of Medicine, Wales, UK
name: Keith Harding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Uppsala, Sweden
name: David Bergqvist, MD
role: PRINCIPAL_INVESTIGATOR
References: