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Completed

NCT Number: NCT00909870

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

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.

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Private Practice FA fur Dermatologie Clinical Centre, Hartberg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermagraft(R)

Device

Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.

Profore

Device

Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

Primary outcomes

  1. Complete Healing of the Study Ulcer by Week 16.

    Time frame: 16 weeks

Secondary outcomes

  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 outcomes

  1. Complete Healing by Week 16: Ulcers <= 12 Months Duration

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Organogenesis

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

Acronym: DEVO

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 29, 2009
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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