Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
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 Objective(s):
- To evaluate the percentage of wound healing every two weeks
- To evaluate the complete ulcer healing every two weeks
- To evaluate the time to complete ulcer healing
- To evaluate the recurrence rate at the end of the follow-up period
- To evaluate pain
- To evaluate the quality of life
Study Design and Treatment Scheme:
This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective study in which data will be collected of subjects with chronic venous leg ulcers receiving standardized conventional therapy (SCT). Subjects will be randomized into two groups receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the effect of BEST on the wound healing process.
Patients answering the eligibility criteria will receive standardized conventional therapy during 4 weeks before actual study start and will then again be evaluated on eligibility according to wound healing rate. Only patients with a wound surface that has not significantly changed (both increased or decreased) will be randomized in the treatment period.
During the treatment period patients will receive SCT with placebo or SCT in combination with bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks.
Patients will be in follow-up period for a maximum of 8 weeks after treatment period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- UZ Gasthuisberg
-
Contact:
- Mieke Flour, MD
- Email: maria.flour@uz.kuleuven.ac.be
-
Principal Investigator:
- Mieke Flour, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
|
2 x 1 hour/day bio-electrical stimulation (BEST) for total period for total period of 8 weeks in combination with standardized conventional therapy (SCT)
Other Names:
|
|
Placebo Comparator: B
|
inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers
Time Frame: every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks)
|
every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate pain
Time Frame: every two weeks
|
every two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mieke Flour, MD, UZ Gasthuisberg, Leuven (Belgium)
- Principal Investigator: Michel de la Brassinne, MD, CHU Sart Tilman, Liege (Belgium)
- Principal Investigator: Bert Boyden, MD, Virga Jesse Ziekenhuis, Hasselt (Belgium)
- Principal Investigator: Hilde Beele, MD, UZ Gent, Belgium
- Principal Investigator: Diane Roseeuw, MD, UZ Brussel (Belgium)
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULTRA-BEST
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