DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency (DESIVI)

Dosing of Electrical Stimulation in Venous Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Venous Insufficiency; Venous Stasis
• Intervention / Treatment: Device: Revitive IX Neuromuscular Stimulation Device

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Actegy Ltd.
• Investigators: Principal Investigator: Raveena Ravikumar, MRCS, Imperial College London

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): August 31, 2016
• Study Completion (ACTUAL): October 31, 2016

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Venous
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Ulcer; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: 15HH2472; 171441 (OTHER: IRAS Project ID); 15/LO/0620 (OTHER: National Research Ethics Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available on request.
• IPD Sharing Time Frame: Post publication.
• IPD Sharing Access Criteria: On direct communication with researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No