REVITIVE for the Treatment of Patients With Venous Insufficiency (RVI)

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

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Venous Insufficiency; Oedema
• Intervention / Treatment: Device: REVITIVE IX

Detailed Description

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:

1. improvement in lower limb oedema
2. improvement in clinical symptoms
3. reduction in lower limb pain and discomfort
4. improvement in quality of life measures
5. device satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W4 8RF
    • Academic Department of Vascular Surgery, Charing Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: REVITIVE IX: actual device; Trial participants will receive the true Revitive IX device	Device: REVITIVE IX; neuromuscular electrical stimulation device
Sham Comparator: REVITIVE IX: sham device; Trial participants will receive a sham device	Device: REVITIVE IX; neuromuscular electrical stimulation device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Actegy Ltd.
• Investigators: Principal Investigator: Alun Davies, MA DM FRCS FHEA, Imperial College London and Imperial College London NHS Trust

Publications and helpful links

General Publications

• Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: electrical stimulation; varicose veins; venous insufficiency; post thrombotic syndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: 13HH0768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data available on request.
• IPD Sharing Time Frame: 12 Months after publication of main study
• IPD Sharing Access Criteria: From listed authors.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (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