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

  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: 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:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014