Last updated on May 2008

Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Venous Leg Ulcers
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Adult subjects ≥ 18 years old, male or female
    Before any subject data is collected, the appropriate written informed consent must
    be obtained (see appendix H).
    Confirmation of venous insufficiency during the last 5 years by Duplex examination
    Chronic venous leg ulcers (>12 weeks) not healing with conventional therapy
    Study ulcer size between 8 to 20 cm² and without clinical signs of infection
    No presence of other ulcers in a radius of 5 cm around the study ulcer
    No surgery for venous insufficiency within the last 6 months
    No arterial insufficiency (ABI between 0,7 and 1,3)
    BMI < 40
    No uncontrolled diabetes or any uncontrolled systemic condition that might impair
    wound healing
    No decubitus wounds
    Ambulant subject
    Written informed consent

You may not be eligible for this study if the following are true:

  • Subjects with implanted electrical devices (e.g. cardiac pacemakers)
    Subjects having a concurrent malignancy or being less than 3 years after the end of
    their cancer therapy
    Subjects with active osteomyelitis
    Pregnant or breast-feeding women

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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