Status:
UNKNOWN
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
Lead Sponsor:
Kingfisher Healthcare
Conditions:
Chronic Venous Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Indication: Subjects with chronic venous leg ulcers Primary Objective: • To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers Secondary Objecti...
Detailed Description
see above
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00678847
Start Date
March 1 2008
End Date
March 1 2009
Last Update
May 16 2008
Active Locations (1)
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1
UZ Gasthuisberg
Leuven, Belgium, 3000