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

Imperial College London

Status: Completed

Conditions: Oedema; Venous Insufficiency; Varicose Veins

Treatments: Device: REVITIVE IX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02114307

13HH0768

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

REVITIVE IX: actual device

Active Comparator group

Description:

Trial participants will receive the true Revitive IX device

Treatment:

Device: REVITIVE IX

REVITIVE IX: sham device

Sham Comparator group

Description:

Trial participants will receive a sham device

Treatment:

Device: REVITIVE IX