Deep Vein Thrombosis
Conditions
Keywords
Deep Vein Thrombosis
Brief summary
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
Interventions
DEVICEgeko
DEVICEPlaster cast
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be in good general health and fitness. 2. Aged between 18 and 65 years. 3. 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) 4. BMI between 18 and 34 5. No history or signs of drug abuse (including alcohol), licit or illicit. 6. 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. 7. Able to understand the Volunteer Information Sheet and signed the written Informed Consent Forms. 8. Able and willing to follow the Protocol requirements.
Exclusion criteria
1. Previous leg fracture. (within the last 12 months) 2. Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations. 3. 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. 4. Peripheral arterial disease (ABPI\<0.9), clinically significant varicose veins or lower limb ulceration. 5. Musculoskeletal disorders (such as pain during exercise of lower limb, rheumatoid or osteoarthritis). 6. Neurological disorders,(such as stroke, multiple sclerosis) 7. Recent surgery (such as abdominal, gynaecological, hip knee replacement). 8. Recent trauma to lower limbs. 9. Chronic Obesity (BMI Index \>34). 10. Pregnancy. 11. Any Medication judged to be significant by the Principal Investigator. 12. Tobacco consumption 13. 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. 14. 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. 15. Any significant illness during the four (4) weeks preceding the screening period of the study. 16. Any contraindication to blood sampling. 17. Donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation. 18. Participation in any clinical study during the 8 weeks preceding the dosing period of the study 19. Fitted with a pacemaker or defibrillator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood flow | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| microcirculatory blood flow | 4 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| acceptability and tolerance (composite endpoint) | 4 hours | None validated questionnaire and a scoring index to assess comfort of the device |
Countries
United Kingdom
Outcome results
None listed