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

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ClinicalTrials.gov Identifier: NCT00909870
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 4, 2013
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Organogenesis

Tracking Information
First Submitted Date  ICMJE May 28, 2009
First Posted Date  ICMJE May 29, 2009
Results First Submitted Date  ICMJE December 31, 2012
Results First Posted Date  ICMJE February 4, 2013
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE June 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2012)
Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
Complete healing of the study ulcer by the end of the treatment period. [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
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. ]
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
Rates of wound healing. [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: December 31, 2012)
Complete Healing by Week 16: Ulcers <= 12 Months Duration [ Time Frame: 16 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Official Title  ICMJE A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Leg Ulcer
Intervention  ICMJE
  • Device: Dermagraft(R)
    Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
  • Device: Profore
    Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Study Arms  ICMJE
  • Experimental: 1
    Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
    Intervention: Device: Dermagraft(R)
  • Active Comparator: 2
    Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
    Intervention: Device: Profore
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2011)
537
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2009)
450
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Estonia,   Germany,   Poland,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909870
Other Study ID Numbers  ICMJE ABH-Dermagraft-001-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Organogenesis
Study Sponsor  ICMJE Organogenesis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Organogenesis
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP