Clinical trial NCT01979328: Geko™ Plaster Cast Study, Deep Vein Thrombosis (DVT) Prophylaxis
Official title: The Efficacy of a Neuromuscular Stimulation Device (Geko™) in Promoting Blood Flow in a Plaster Cast as a Way of Offering Mechanical DVT Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deep Vein Thrombosis
Keywords: Deep Vein Thrombosis
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Blood flow
timeFrame: 4 hours
Secondary outcomes:
measure: microcirculatory blood flow
timeFrame: 4 hours
Other outcomes:
measure: acceptability and tolerance (composite endpoint)
timeFrame: 4 hours
Locations:
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References:
citation: 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.