Clinical trial NCT02114307: REVITIVE for the Treatment of Patients With Venous Insufficiency
Official title: REVITIVE for the Treatment of Patients With Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Oedema
Varicose Veins
Keywords: electrical stimulation
venous insufficiency
post thrombotic syndrome
varicose veins
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Actegy Ltd.
First posted: 2014-04-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
timeFrame: 0 and 6 weeks
Secondary outcomes:
measure: Changes in Limb Swelling, Volume
timeFrame: 0 and 6 weeks
measure: Clinical Symptoms
timeFrame: 0 and 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Academic Department of Vascular Surgery, Charing Cross Hospital
Study officials:
affiliation: Imperial College London and Imperial College London NHS Trust
name: Alun Davies, MA DM FRCS FHEA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.