REVITIVE for the Treatment of Patients With Venous Insufficiency

Varicose Veins Clinical Trial

— RVI  

Official title:

REVITIVE for the Treatment of Patients With Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114307
• Other study ID #: 13HH0768
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: October 1, 2014

Study information

• Verified date: September 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 1, 2014
• Est. primary completion date: October 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oedema
• Varicose Veins
• Venous Insufficiency

Intervention

Device:
• REVITIVE IX
neuromuscular electrical stimulation device

Locations

Country	Name	City	State
United Kingdom	Academic Department of Vascular Surgery, Charing Cross Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Actegy Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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