Venous Insufficiency and Neuromuscular Stimulation

Venous Insufficiency Clinical Trial

— VeINS  

Official title:

Venous Insufficiency and Neuromuscular Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137499
• Other study ID #: 13/WM/0027
• Secondary ID: CR02072
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Disease
• Deep Venous Obstruction
• Venous Insufficiency

Intervention

Device:
• geko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	Hammersmith	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change of Haemodynamic Flow	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	Improvement in Venous Symptoms	Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)	6 weeks
Secondary	Leg Volume	Measured using ankle and calf circumference, and multiplying using "inverted cone" method	6 weeks