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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: February 11, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show 70 Study Locations
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: February 11, 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 May 23, 2013