Geko™ Plaster Cast Study, Deep Vein Thrombosis (DVT) Prophylaxis
NCT ID: NCT01979328
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Study arm
geko neuromuscular electrostimulation
geko
Plaster cast
Interventions
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geko
Plaster cast
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Southampton University Hospital
Southampton, , United Kingdom
Countries
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References
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Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.
Other Identifiers
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THRIVE-III
Identifier Type: -
Identifier Source: org_study_id