Chronic Venous Disease, Deep Venous Obstruction, Venous Insufficiency
Conditions
Keywords
Deep venous obstruction, Venous insufficiency
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
Interventions
DEVICEgeko device
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
Sponsors
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subjects Healthy participants treated with Small transcutaneous electrical stimulator | 10 |
| Superficial Venous Insufficiency Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator | 10 |
| Deep Venous Insufficiency Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator | 10 |
| Deep Venous Obstruction Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Healthy Subjects | Superficial Venous Insufficiency | Deep Venous Insufficiency | Deep Venous Obstruction | Total |
|---|---|---|---|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 10 | 55 years STANDARD_DEVIATION 15 | 58.6 years STANDARD_DEVIATION 18 | 53.2 years STANDARD_DEVIATION 16 | 56 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 2 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 8 Participants | 7 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: baseline, 20 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Subjects | Percentage Change of Haemodynamic Flow | Peak velocity | 34.8 % change |
| Healthy Subjects | Percentage Change of Haemodynamic Flow | TAMV time-averaged mean velocity | -14.2 % change |
| Healthy Subjects | Percentage Change of Haemodynamic Flow | Volume flow | -22.5 % change |
| Superficial Venous Insufficiency | Percentage Change of Haemodynamic Flow | Volume flow | 37.5 % change |
| Superficial Venous Insufficiency | Percentage Change of Haemodynamic Flow | TAMV time-averaged mean velocity | 28.1 % change |
| Superficial Venous Insufficiency | Percentage Change of Haemodynamic Flow | Peak velocity | 62.8 % change |
| Deep Venous Insufficiency | Percentage Change of Haemodynamic Flow | Peak velocity | 9 % change |
| Deep Venous Insufficiency | Percentage Change of Haemodynamic Flow | Volume flow | 17.4 % change |
| Deep Venous Insufficiency | Percentage Change of Haemodynamic Flow | TAMV time-averaged mean velocity | 28.2 % change |
| Deep Venous Obstruction | Percentage Change of Haemodynamic Flow | Volume flow | 5.9 % change |
| Deep Venous Obstruction | Percentage Change of Haemodynamic Flow | TAMV time-averaged mean velocity | -5.1 % change |
| Deep Venous Obstruction | Percentage Change of Haemodynamic Flow | Peak velocity | 14.8 % change |
Secondary
Improvement in Venous Symptoms
Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)
Time frame: 6 weeks
Population: Data not collected
Secondary
Leg Volume
Measured using ankle and calf circumference, and multiplying using inverted cone method
Time frame: 6 weeks
Population: Data not collected