REVITIVE for the Treatment of Patients With Venous Insufficiency

Study Overview
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Brief Summary
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To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.

Detailed Description
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This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each. Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card. Primary outcome measure: a) improvement in venous haemodynamics. Secondary outcome measures: improvement in lower limb oedema improvement in clinical symptoms reduction in lower limb pain and discomfort improvement in quality of life measures device satisfaction.

Official Title
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REVITIVE for the Treatment of Patients With Venous Insufficiency

Conditions
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Oedema, Venous Insufficiency, Varicose Veins

Intervention / Treatment
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* Device: REVITIVE IX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability 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 (C2-C5 CEAP classified) Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device. Blood pressure currently under moderate control (<160/100mmHg) No current foot ulceration. Exclusion Criteria: Has insufficient ability to understand the subject information sheet, consent form and verbal instruction. Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP). Has any metal implants. Pregnant. Has a cardiac pacemaker, AICD or other implanted electrical device. Has an existing DVT. Has an acute medical condition other than chronic venous insufficiency. Has recent lower limb injury or lower back pain. Has current foot ulceration or other skin ulcers. Has cardiovascular disease. Has foot deformities. 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 |
| --- | --- |
| Active Comparator: REVITIVE IX: actual device<br>Trial participants will receive the true Revitive IX device | Device: REVITIVE IX<br>* neuromuscular electrical stimulation device<br>|
| Sham Comparator: REVITIVE IX: sham device<br>Trial participants will receive a sham device | Device: REVITIVE IX<br>* neuromuscular electrical stimulation device<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 | Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity | 0 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Limb Swelling, Volume | Lower limb oedema measured before and after using the device at 0 and 6 weeks using a perimeter. Limb volume was measured using an optoelectronic limb volumeter. Patients using compression stockings were advised to remove stockings 2 h prior to their appointment. Measurements were taken with the patient seated and the affected leg in a horizontal position. Five readings were taken before and after device usage at Week 0 and Week 6 | 0 and 6 weeks | 
| Clinical Symptoms | Change in clinical symptoms as assessed by the Venous Clinical Severity Score (VCSS) from 0 to 6 weeks, lower score means improvement. Maximum score on VCSS is 30. Minimum score is 0. | 0 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins