Varicose Veins Clinical Trial
Official title:
Prospective Observational Series to Establish the Haemodynamic Efficacy and Tolerability of gekoTM Device in Patients With Lower Limb Vascular Disease
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
The geko™ device, (CE 558928; British Standards Institute notified body 0086),is a wearable,
discrete, self-contained stimulation unit that adheres to the skin (see www.gekodevices.com).
The, geko™ triggers small electrical impulses that gently activate the common peroneal nerve
within the popliteal fossa, behind the knee, in turn activating the venous muscle pumps of
the calf and foot. Substantive increases in lower limb blood flow have been demonstrated to
improve arterial, venous and microcirculatory blood flow with no reported morbidity.
Environmental Conditions The examinations will be carried out in a designated temperature
controlled clinical room in the Vascular Lab at Hull Royal Infirmary. Participants will be
required to abstain from vigorous exercise, nicotine, caffeine and fatty foods prior to their
examination. They will be required to wear light garments with their legs exposed.
The geko™ device will be applied to outer/ posterior aspect of the knee whilst the subjects
are semi-recumbent, with their knees flexed. The participants will be given 30 minutes in the
quiet, environmentally controlled room prior to commencement of measurement to enable
equilibration.
Assessments Participants will complete the McGill Pain questionnaire prior to device
activation Participants will have the geko™ device applied whilst semi-recumbent with their
knees flexed. The intensity will be increased until visible muscle stimulation is evident
(concentric isotonic contractions) or until patient tolerance is reached
- Laser Doppler imaging will be used to assess microcirculation flow on the dorsum of both
feet at:
1. Baseline (rest)
2. 5 minute intervals while the geko™ device is active
3. 30 minutes following removal of the device Laser Doppler flowmetry is a
reproducible, objective, non-invasive measurement which can be used to evaluate
real time cutaneous blood flow. The low powered light is conducted via glass fibres
to a probe attached to the skin and is scattered by the movement of blood cells
inducing a Doppler shift. This allows information on flux and cell velocity to be
recorded. The system to be used for this trial is the Moor Instruments DT-4 mains
unit with integrated bilateral lasers.
- Ultrasound Doppler arterial flow velocity and blood volume flow within the femoral
artery (mid thigh) bilaterally at:
1. Baseline (rest)
2. 30 minutes while the device is active
- Ultrasound Doppler flow velocity in femoral vein (mid thigh) bilaterally at:
1. Baseline (rest)
2. 40 minutes while the geko is active
- Vascular Endothelial Growth Factor (VEGF), Tissue Plasminogen Activator antigen (TPA
antigen), Full blood count (FBC) and Plasminogen activator inhibitor-1 (PAI-1): 15 mls
of blood to be taken from both femoral veins at:
1. Baseline (rest)
2. 45 minutes while the geko™ device is active ELISA analysis will be carried out on
samples (see appendix). Vascular Endothelial Growth Factor - Therapies which can
lead to the development of new, collateral blood vessels, are of particular
interest in the field of peripheral arterial disease where narrowing or blockages
in existing blood vessels result in tissue ischaemia. Vascular endothelial growth
factor (VEGF) is a signal protein produced by cells that stimulates the growth of
new blood vessels from pre-existing vessels. Several previous studies have shown
that electrical stimulation increases VEGF levels and in turn increases vessel
density in muscles.
Tissue plasminogen activator (tPA) is a protein involved in the breakdown of blood clots. As
a result it has therapeutic uses in clinical medicine to treat thromboses and emboli.
Electrical stimulation has been previously shown to provoke an acute release of tPA into the
circulation, although it appears that this response decreases with repeated stimulations. Use
of the geko™ device has been shown to result in a significant decrease in Tissue Plasminogen
Activator (tPA) antigen which is indicative of increased fibrinolytic activity.
Plasminogen activator inhibitor- 1 (PAI-1) is the primary inhibitor of plasminogen activators
and inactivates tissue plasminogen activator (t-PA) and urokinase-type plasminogen activator
(u-PA). PAI-1 is an important inhibitor of the fibrinolytic system, and elevated levels could
suppress fibrinolysis and result in an increased risk of thrombosis. Increased PAI-1 levels
have been shown to be associated with a number of atherosclerotic risk factors, PAI-1 has
been shown to act as a prothrombic factor in both arterial and venous thromboembolic
disorders.
- Ankle Brachial Pressure Index at baseline and post removal of geko™- utilising both
Posterior Tibial Artery and Anterior Tibial Artery
- Maximum calf circumference at baseline and post removal of geko™
- Three blood pressure and heart rate measurements will be taken bilaterally at baseline
and @ 30 minutes while the device is active. The mean of the three values will be used
for comparison.
- Patient tolerance/ acceptability + Nurse tolerance/ ease of application Questionnaire
using Visual Analogue Scores and Verbal Rating Scores to be completed following removal
of geko™ device (see appendix)
- The McGill Pain Questionnaire to be completed following device removal
;
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