Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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see above

Official Title
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Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Conditions
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Chronic Venous Leg Ulcers

Intervention / Treatment
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* Device: KFH NOVO (inactive) + SCT
* Device: KFH Novo (BEST) + SCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br> | Device: KFH NOVO (inactive) + SCT<br>* inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)<br>* Other names: KFH NOVO;|
| Active Comparator: A<br> | Device: KFH Novo (BEST) + SCT<br>* 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)<br>* Other names: KFH Novo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers |  | every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pain |  | every two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bio-electrical stimulation therapy, chronic venous ulcers, microcurrent, chronic wounds, complete healing