Venous Insufficiency and Neuromuscular Stimulation (VeINS)

Imperial College London

Status: Completed

Conditions: Chronic Venous Disease; Deep Venous Obstruction; Venous Insufficiency

Treatments: Device: geko device

Study type: Interventional

Funder types: Other

Identifiers

NCT02137499

CR02072 (Other Identifier)

13/WM/0027

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Healthy subjects

Active Comparator group

Description:

Healthy subjects, free from vascular disease

Treatment:

Device: geko device

Superficial venous insufficiency

Experimental group

Description:

Clinically symptomatic and ultrasound evidence of superficial venous insufficiency

Treatment:

Device: geko device

Deep venous insufficiency

Experimental group

Description:

Clinically symptomatic and ultrasound evidence of deep venous insufficiency

Treatment:

Device: geko device

Deep venous obstruction

Experimental group

Description:

Clinically symptomatic and ultrasound evidence of deep venous obstruction

Treatment:

Device: geko device