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

May 28, 2009
August 9, 2013
June 2009
May 2011   (final data collection date for primary outcome measure)
Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete healing of the study ulcer by the end of the treatment period. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00909870 on ClinicalTrials.gov Archive Site
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.
Rates of wound healing. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete Healing by Week 16: Ulcers <= 12 Months Duration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
 
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Leg Ulcer
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
537
August 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   United States,   United Kingdom,   South Africa,   Germany,   Estonia,   Sweden,   Austria
 
NCT00909870
ABH-Dermagraft-001-08
No
Shire Regenerative Medicine, Inc.
Shire Regenerative Medicine, Inc.
Not Provided
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
Shire Regenerative Medicine, Inc.
August 2013

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