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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Dermagraft(R) Device: Profore Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Complete Healing by Week 16: Ulcers <= 12 Months Duration [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909870


Locations
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Sponsors and Collaborators
Organogenesis
Investigators
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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
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Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT00909870    
Other Study ID Numbers: ABH-Dermagraft-001-08
First Posted: May 29, 2009    Key Record Dates
Results First Posted: February 4, 2013
Last Update Posted: June 18, 2018
Last Verified: May 2018
Keywords provided by Organogenesis:
Venous leg ulcer
randomized trial
clinical trial
Dermagraft
compression therapy
 surgical debridement
venous stasis
chronic ulcer
chronic wound
fibroblasts
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases