Clinical trial NCT01981733: Improving Lower Limb Blood Flow in Healthy Adult Volunteers
Official title: A Study to Determine the Effects of a Novel Method for Improving Lower Limb Blood Flow in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deep Vein Thrombosis
Keywords: Deep Vein Thrombosis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: BASIC_SCIENCE

Brief summary: The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb using electrical stimulation. Increases in lower limb blood flow improve venous return and thereby reduce venous stasis. Since stasis is one of the compounding factors in the development of deep vein thrombosis, the risk of developing thrombosis should theoretically be proportionally reduced. This technique may prove to be a useful tool in preventing and reducing the incidence of deep vein thrombosis in both medical and surgical patients together with passengers undertaking significant duration travel (as travel - related deep vein thrombosis is not exclusively related to flying).


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 within 48 hours prior to commencement of the each study phase.
4. BMI between 18 and 34
5. No history or signs of drug abuse (including alcohol), licit or illicit.
6. Has not to 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. Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations.
2. History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism).
3. Peripheral arterial disease (ABPI \< 0.9), varicose veins or lower limb ulceration.
4. Musculoskeletal disorders (such as pain during exercise of lower limb).
5. Recent surgery (such as abdominal, gynaecological, hip knee replacement).
6. Recent trauma to lower limb.
7. Chronic Obesity (BMI Index \>34).
8. Pregnancy.
9. Any Medication judged to be significant by the Principal Investigator (such as anticoagulants, agents with significant vasoactive activity, Oestrogen pill, 'morning-after pill' or HRT).
10. Tobacco consumption
11. 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.
12. 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.
13. Any significant illness during the four (4) weeks preceding the screening period of the study.
14. Any contraindication to blood sampling.
15. Donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation.
16. Participation in any clinical study during the 8 weeks preceding the dosing period of the study

Primary outcomes:
measure: Changes in blood flow and volume, together with microcirculatory velocity were measured
timeFrame: 30 mins with 10 min washouts
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
affiliation: St. Bartholomew's Hospital
name: Arthur Tucker, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References: