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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT00909870
First received: May 28, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Venous Leg Ulcer
Device: Dermagraft(R)
Device: Profore
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

Resource links provided by NLM:


Further study details as provided by Shire Regenerative Medicine, Inc.:

Primary Outcome Measures:
  • Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-to-Complete Healing [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.


Other Outcome Measures:
  • Complete Healing by Week 16: Ulcers <= 12 Months Duration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 537
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Device: Dermagraft(R)
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Active Comparator: 2
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Device: Profore
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909870

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
HOPE Research Institute
Phoenix, Arizona, United States, 85050
University of Arizona College of Medicine
Tuscon, Arizona, United States, 85724
Southern Arizona VA Health Care System (SAVAHCS)
Tuscon, Arizona, United States, 85723
United States, California
Dr. Jagpreet S. Mukker
Fresno, California, United States, 93726
VA Northern California Health Care System
Mather, California, United States, 95665
Sutter Roseville Medical Center Wound Care Center
Roseville, California, United States, 95661
Therapeutics Clinical Research
San Diego, California, United States, 92123
General Vascular Surgery Group
San Leandro, California, United States, 94578
Pacific Wound Center
Stockton, California, United States, 95204
United States, Connecticut
North American Center for Limb Preservation
New Haven, Connecticut, United States, 06515
United States, District of Columbia
Providence Hospital
Washington, District of Columbia, United States, 20017
United States, Florida
Foot & Ankle Associates of Florida
Alamonte Springs, Florida, United States, 32701
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Comprehensive Wound Healing Center
Clearwater, Florida, United States, 33756
Osceola Regional Wound Care Center
Kissimmee, Florida, United States, 34741
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Doctor's Research Network
South Miami, Florida, United States, 33143
Robert Snyder, DPM, CWS
Tamarac, Florida, United States, 33321
United States, Georgia
Aiyan Diabetes Center
Evans, Georgia, United States, 30809
United States, Iowa
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314-1597
United States, Massachusetts
Boston Medical Center, Department of Vascular Surgery
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Covenant Wound Healing Center
Saginaw, Michigan, United States, 48602
United States, Missouri
Heartland Regional Medical Center
St Joseph, Missouri, United States, 64506
United States, Nevada
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Overlook Hospital Wound Healing Program
Summit, New Jersey, United States, 07901
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina Division of Vascular Surgery
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Saint Vincent Health Center
Erie, Pennsylvania, United States, 16544
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Jackson Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Utah
Dixie Regional Meidcal Center
St George, Utah, United States, 84770
Austria
Private Practice FA fur Dermatologie Clinical Centre
Hartberg, Austria, 8230
Private Practice / Clinical Centre
Vienna, Austria, 1220
Estonia
East-Tallinn Central Hospital
Tallinn, Estonia, 11312
Germany
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg, Germany, D-79100
Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, Germany, D-22177
Poland
Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
Gdynia, Poland, 81-415
AKMed Medical Centre
Krakow, Poland, 30-312
5 Wojskowy Szpital Kliniczny w Krakowie
Krakow, Poland, 30-901
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
S. Zeromski Hospital Krakow
Krakow, Poland, 31-913
NZOZ Clinical for Vascular Diseases
Krakow, Poland, 30-321
NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
Lodz, Poland, 90-265
Clinical Trials Centre
Lublin, Poland, 20-022
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sacz, Poland, 33-300
"Medyk" Medical Center
Rzeszow, Poland, 35-055
General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
Warszawa, Poland, 02-097
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
Wroclaw, Poland, 54-610
South Africa
Langeberg Medical Centre
Kraaifontein, Cape Town, South Africa, 7570
Worthwhile Clinical Trials Lakeview Hospital
Benoni, Johannesburg, South Africa, 1500
Edenvale Hospital, c/o CEO Secretary
Edenvale, Johhanesburg, South Africa, 1610
GCT-Mercantile Clinical Trial Centre
Korsten, Port Elizabeth, South Africa, 6014
Synexus SA Watermeyer Clinical Research Centre
Meyerspark, Pretoria, South Africa
Josha Research
Bloemfontein, South Africa, 9301
Dr. D.R.Lakha, Private Practice
Johannesburg, South Africa, 1835
I Engelbrecht Research
Lyttelton, South Africa, 0157
Middelburg Hospital
Middelburg, South Africa, 1055
Uncedo Clinical Research Services Mercantile Hospital
Port Elizabeth, South Africa, 6014
Cachetmed Medical Centre
Potchefstroom, South Africa, 2531
Randles Road Medical Centre
Sydenham, DURBAN, South Africa, 4091
Clinical Projects Research SA
Worcester, South Africa, 6850
Sweden
University of Lund Dept of Dermatology
Lund, Sweden
Overlakare/Klinikchef Hud Kliniken
Stockholm, Sweden, SE-118 83
United Kingdom
Wound Clinic on Fairfield
Croydon, Surrey, United Kingdom, CR7 7YE
Bradford Hospitals NHS Trust
Bradford, United Kingdom, BD9 6RJ
Cardiff University
Cardiff, United Kingdom, CF14 4XN
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Shire Regenerative Medicine, Inc.
Investigators
Principal Investigator: William Marston, MD University of North Carolina School of Medicine, Chapel Hill, NC
Principal Investigator: Keith Harding, MD Cardiff University School of Medicine, Wales, UK
Principal Investigator: David Bergqvist, MD University of Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier: NCT00909870     History of Changes
Other Study ID Numbers: ABH-Dermagraft-001-08
Study First Received: May 28, 2009
Results First Received: December 31, 2012
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire Regenerative Medicine, Inc.:
Venous leg ulcer
randomized trial
clinical trial
Dermagraft
compression therapy
surgical debridement
venous stasis
chronic ulcer
chronic wound
fibroblasts

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014