NCT02114307

REVITIVE for the Treatment of Patients With Venous Insufficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Insufficiency
• Oedema
• Varicose Veins

Interventions

Type	Name	Description
DEVICE	REVITIVE IX	neuromuscular electrical stimulation device

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-04-15
• Last updated: 2019-10-10
• Results posted: 2019-10-10

Locations

1 site across 1 country: United Kingdom