DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Not Applicable

Completed

• Conditions: Varicose Veins; Venous Insufficiency; Venous Stasis
• Interventions: Device: Revitive IX Neuromuscular Stimulation Device

• Registration Number: NCT03850496
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-10-31
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Results First Submitted: 2019-06-10
• Results First Submitted QC: 2019-09-02
• Results First Posted: 2019-09-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Revitive IX Neuromuscular Stimulation Device	Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.
Group C	Revitive IX Neuromuscular Stimulation Device	Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Limb Volume	0 and 6 weeks	Change in limb volume assessed in ml.
Generic Quality of Life - EQ-VAS	0 and 6 weeks	Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
Generic Quality of Life - EQ-5D-5L	0 and 6 weeks	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).
Microcirculatory Blood Flow	0 and 6 weeks.	Microcirculatory blood flow measure utilising flux arbitrary units.
Patient Compliance	6 weeks.	Compliance with device usage assessed with a patient completed diary.
Venous Flow Parameters - PV	0 and 6 weeks	Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Venous Flow Parameters - VF	0 and 6 weeks	Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Venous Clinical Severity	0 and 6 weeks.	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
Generic Quality of Life - SF-12	0 and 6 weeks	Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
Disease Specific Quality of Life	0 weeks and 6 weeks	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.