Venous Insufficiency and Neuromuscular Stimulation

Not Applicable

Completed

• Conditions: Chronic Venous Disease; Deep Venous Obstruction; Venous Insufficiency
• Interventions: Device: geko device

• Registration Number: NCT02137499
• Lead Sponsor: Imperial College London

Brief Summary

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-13
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2019-09-18
• Results First Submitted QC: 2019-09-18
• Status Verified: 2019-10
• Results First Posted: 2019-10-11
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superficial venous insufficiency	geko device	Clinically symptomatic and ultrasound evidence of superficial venous insufficiency
Healthy subjects	geko device	Healthy subjects, free from vascular disease
Deep venous obstruction	geko device	Clinically symptomatic and ultrasound evidence of deep venous obstruction
Deep venous insufficiency	geko device	Clinically symptomatic and ultrasound evidence of deep venous insufficiency

Primary Outcome Measures

Name	Time	Method
Percentage Change of Haemodynamic Flow	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charing Cross Hospital; 🇬🇧 Hammersmith, London, United Kingdom