DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Not Applicable

Completed

Conditions: Varicose Veins
Venous Insufficiency
Venous Stasis

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

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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.