Improving Lower Limb Blood Flow in Healthy Adult Volunteers

Deep Vein Thrombosis Clinical Trial

— THRIVE-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981733
• Other study ID #: THRIVE-1
• Status: Completed
• Phase: Phase 0
• First received: November 5, 2013
• Last updated: November 5, 2013
• Start date: March 2005

Study information

• Verified date: November 2013
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• geko
The geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve

Locations

Country	Name	City	State
United Kingdom	St. Bartholomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No