DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Study Overview
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Brief Summary
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This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.

Official Title
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Dosing of Electrical Stimulation in Venous Insufficiency

Conditions
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Varicose Veins, Venous Stasis, Venous Insufficiency

Intervention / Treatment
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* Device: Revitive IX Neuromuscular Stimulation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic venous insufficiency who have the following are eligible for the study: Able to understand the study and provide meaningful written informed consent for the study. Willing, able, and committed to participate in the procedures for the full length of the study. All ethnic groups, male or female above the age of 18 years. Diagnosis of chronic venous insufficiency (C3-C5 CEAP Classification) Blood pressure currently under moderate control (< 160/100mmHg) No current foot ulceration Exclusion Criteria: Patients meeting any of the following criteria are to be excluded: Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol Pregnant Has a cardiac pacemaker, AICD or other implanted electrical device Has an Existing DVT. Has recent lower limb injury or lower back pain Has current foot ulceration or other skin ulcers Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study. Has an ABPI < 0.8

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>No device utilised for 6 weeks. | |
| Experimental: Group B<br>Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks. | Device: Revitive IX Neuromuscular Stimulation Device<br>* Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.<br>|
| Experimental: Group C<br>Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks. | Device: Revitive IX Neuromuscular Stimulation Device<br>* Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline. | 0 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Flow Parameters - PV | Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline. | 0 and 6 weeks | 
| Venous Flow Parameters - VF | Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline. | 0 and 6 weeks | 
| Microcirculatory Blood Flow | Microcirculatory blood flow measure utilising flux arbitrary units. | 0 and 6 weeks. | 
| Limb Volume | Change in limb volume assessed in ml. | 0 and 6 weeks | 
| Venous Clinical Severity | Clinical severity of venous disease as measured by the venous clinical severity score (VCSS). Scale measure from 0-30, with higher values indicating worse status. It is made up of 10 variables scored from 0-3 | 0 and 6 weeks. | 
| Patient Compliance | Compliance with device usage assessed with a patient completed diary. | 6 weeks. | 
| Generic Quality of Life - EQ-5D-5L | Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead). | 0 and 6 weeks | 
| Generic Quality of Life - SF-12 | Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks. | 0 and 6 weeks | 
| Generic Quality of Life - EQ-VAS | Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better. | 0 and 6 weeks | 
| Disease Specific Quality of Life | quality of life as assessed on the Aberdeen varicose vein questionnaire scale (0-100). This is a patient reported quality of life measure, which assesses symptoms of varicose veins. Higher values are worse. | 0 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous