REVITIVE for the Treatment of Patients With Venous Insufficiency

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2014-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

NCT03850496

Varicose Veins Venous Stasis Venous Insufficiency

COMPLETED NA

Venous Occlusion and Limb Swelling

NCT02241343

Venous Occlusion

TERMINATED NA

Venous Insufficiency and Neuromuscular Stimulation

NCT02137499

Chronic Venous Disease Venous Insufficiency Deep Venous Obstruction

COMPLETED NA

ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations

NCT01528293

Chronic Venous Hypertension With Ulcer

TERMINATED NA

Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

NCT02015221

Chronic Venous Insufficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Insufficiency Oedema Varicose Veins

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

REVITIVE IX: actual device

Trial participants will receive the true Revitive IX device

Group Type ACTIVE_COMPARATOR

REVITIVE IX

Intervention Type DEVICE

neuromuscular electrical stimulation device

REVITIVE IX: sham device

Trial participants will receive a sham device

Group Type SHAM_COMPARATOR

REVITIVE IX

Intervention Type DEVICE

neuromuscular electrical stimulation device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REVITIVE IX

neuromuscular electrical stimulation device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No