REVITIVE for the Treatment of Patients With Venous Insufficiency

Launched by IMPERIAL COLLEGE LONDON · Apr 11, 2014

Keywords

ClinConnect Summary

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 treatme...

Gender

ALL

Eligibility criteria

• 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.