Improving Lower Limb Blood Flow in Healthy Adult Volunteers (THRIVE-1)

A Study to Determine the Effects of a Novel Method for Improving Lower Limb Blood Flow in Healthy Adult Volunteers

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).

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Device: geko

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device	Device: geko; The geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve; Other Names: geko TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood flow and volume, together with microcirculatory velocity were measured	Changes in blood flow and volume, together with microcirculatory velocity were measured using laser Doppler flowmetry (Laser Doppler Perfusion & Temperature Monitor DRT4; Moor Instruments Ltd, UK) and colour flow duplex ultrasound (Philips IU22; Philips Healthcare, USA).	30 mins with 10 min washouts

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: Arthur Tucker, BSc PhD, St. Bartholomew's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (ESTIMATE): November 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 11, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: THRIVE-1