Geko™ Plaster Cast Study, Deep Vein Thrombosis (DVT) Prophylaxis

Study Overview
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Brief Summary
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The primary objective of this study is to examine the flow characteristics of deep venous flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the application of a plaster and with a geko™ device in healthy volunteers

Official Title
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The Efficacy of a Neuromuscular Stimulation Device (Geko™) in Promoting Blood Flow in a Plaster Cast as a Way of Offering Mechanical DVT Prophylaxis

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Device: geko
* Device: Plaster cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be in good general health and fitness. Aged between 18 and 65 years. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound) BMI between 18 and 34 No history or signs of drug abuse (including alcohol), licit or illicit. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the thirty (30) days preceding the study, and agrees not to use any medications during the course of the study without informing the Research Team. Able to understand the Volunteer Information Sheet and signed the written Informed Consent Forms. Able and willing to follow the Protocol requirements. Exclusion Criteria: Previous leg fracture. (within the last 12 months) Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations. History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism) or familiar history of such. Peripheral arterial disease (ABPI<0.9), clinically significant varicose veins or lower limb ulceration. Musculoskeletal disorders (such as pain during exercise of lower limb, rheumatoid or osteoarthritis). Neurological disorders,(such as stroke, multiple sclerosis) Recent surgery (such as abdominal, gynaecological, hip knee replacement). Recent trauma to lower limbs. Chronic Obesity (BMI Index >34). Pregnancy. Any Medication judged to be significant by the Principal Investigator. Tobacco consumption History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, endocrine, neurological, dermatological, rheumatologic, metabolic (including diabetes), psychiatric, haematological (especially in relation to clotting or coagulation), or systemic disease judged to be significant. A pulse rate of less than 50 beats/minute, a sitting systolic blood pressure >160 or <80 mmHg and/or a sitting diastolic pressure of >90 or <60 mmHg. Any significant illness during the four (4) weeks preceding the screening period of the study. Any contraindication to blood sampling. Donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation. Participation in any clinical study during the 8 weeks preceding the dosing period of the study Fitted with a pacemaker or defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>geko neuromuscular electrostimulation | Device: geko<br> <br> Device: Plaster cast<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microcirculatory blood flow |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Vein Thrombosis