DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Varicose Veins Clinical Trial

— DESIVI  

Official title:

Dosing of Electrical Stimulation in Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850496
• Other study ID #: 15HH2472
• Secondary ID: 17144115/LO/0620
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: July 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with chronic venous insufficiency who have the following are eligible for the study:

• Able 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 (C3-C5 CEAP Classification)

• Blood pressure currently under moderate control (< 160/100mmHg)

• No current foot ulceration

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded:

• Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol

• Pregnant

• Has a cardiac pacemaker, AICD or other implanted electrical device

• Has an Existing DVT.

• Has recent lower limb injury or lower back pain

• Has current foot ulceration or other skin ulcers

• 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

• Varicose Ulcer
• Varicose Veins
• Venous Insufficiency
• Venous Stasis

Intervention

Device:
• Revitive IX Neuromuscular Stimulation Device
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Actegy Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV	Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.	0 and 6 weeks
Secondary	Venous Flow Parameters - PV	Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.	0 and 6 weeks
Secondary	Venous Flow Parameters - VF	Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.	0 and 6 weeks
Secondary	Microcirculatory Blood Flow	Microcirculatory blood flow measure utilising flux arbitrary units.	0 and 6 weeks.
Secondary	Limb Volume	Change in limb volume assessed in ml.	0 and 6 weeks
Secondary	Venous Clinical Severity	Clinical severity of venous disease as measured by the venous clinical severity score (VCSS). Scale measure from 0-30, with higher values indicating worse status. It is made up of 10 variables scored from 0-3	0 and 6 weeks.
Secondary	Patient Compliance	Compliance with device usage assessed with a patient completed diary.	6 weeks.
Secondary	Generic Quality of Life - EQ-5D-5L	Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead).	0 and 6 weeks
Secondary	Generic Quality of Life - SF-12	Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.	0 and 6 weeks
Secondary	Generic Quality of Life - EQ-VAS	Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.	0 and 6 weeks
Secondary	Disease Specific Quality of Life	quality of life as assessed on the Aberdeen varicose vein questionnaire scale (0-100). This is a patient reported quality of life measure, which assesses symptoms of varicose veins. Higher values are worse.	0 weeks and 6 weeks