Venous Insufficiency and Neuromuscular Stimulation (VeINS)

October 11, 2019 updated by: Imperial College London
The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY AIMS

  1. To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.
  2. To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.

METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound.

The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground).

ENDPOINTS Primary end-point

  • Increase in venous flow Secondary end points
  • Improvement in clinical symptoms at 6 weeks, as judged by questionnaire
  • Reduction in absolute leg diameter and volume at 6 weeks

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London
      • Hammersmith, London, United Kingdom, W6 8RF
        • Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Group 1

  • Inclusion criteria - 18+ years old, 17<BMI<30
  • Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 2

  • Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US
  • Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 3

  • Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous insufficiency (CEAP C2-6) confirmed with duplex US
  • Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 4

  • Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous obstruction confirmed with duplex US
  • Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Healthy subjects
Healthy subjects, free from vascular disease
Device: geko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
EXPERIMENTAL: Superficial venous insufficiency
Clinically symptomatic and ultrasound evidence of superficial venous insufficiency
Device: geko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
EXPERIMENTAL: Deep venous insufficiency
Clinically symptomatic and ultrasound evidence of deep venous insufficiency
Device: geko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
EXPERIMENTAL: Deep venous obstruction
Clinically symptomatic and ultrasound evidence of deep venous obstruction
Device: geko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change of Haemodynamic Flow
Time Frame: baseline, 20 minutes
Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.
baseline, 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Venous Symptoms
Time Frame: 6 weeks
Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)
6 weeks
Leg Volume
Time Frame: 6 weeks
Measured using ankle and calf circumference, and multiplying using "inverted cone" method
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (ESTIMATE)

May 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/WM/0027
  • CR02072 (OTHER: Imperial College London)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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