Clinical trial NCT02137499: Venous Insufficiency and Neuromuscular Stimulation
Official title: Venous Insufficiency and Neuromuscular Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Disease
Venous Insufficiency
Deep Venous Obstruction
Keywords: Deep venous obstruction
Venous insufficiency
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Percentage Change of Haemodynamic Flow
timeFrame: baseline, 20 minutes
Secondary outcomes:
measure: Improvement in Venous Symptoms
timeFrame: 6 weeks
measure: Leg Volume
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hammersmith
country: United Kingdom
facility: Charing Cross Hospital
state: London
Study officials:
affiliation: Imperial College London
name: Alun Davies
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.