Geko™ Plaster Cast Study, Deep Vein Thrombosis (DVT) Prophylaxis (THRIVE-III)

The Efficacy of a Neuromuscular Stimulation Device (Geko™) in Promoting Blood Flow in a Plaster Cast as a Way of Offering Mechanical DVT Prophylaxis

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University 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)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study arm; geko neuromuscular electrostimulation	Device: geko; Device: Plaster cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood flow	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
microcirculatory blood flow	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability and tolerance (composite endpoint)	None validated questionnaire and a scoring index to assess comfort of the device	4 hours

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (ESTIMATE): November 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: October 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-III