Venous Insufficiency and Neuromuscular Stimulation (VeINS)

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 AIMS 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. 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

Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

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.

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

Williams KJ, Moore HM, Ellis M, Davies AH. Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease. Vasc Health Risk Manag. 2021 Dec 1;17:771-778. doi: 10.2147/VHRM.S320883. eCollection 2021.