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

Deep Vein Thrombosis Clinical Trial

— THRIVE-III  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979328
• Other study ID #: THRIVE-III
• Status: Completed
• Phase: Phase 0
• First received: October 21, 2013
• Last updated: November 4, 2013
• Start date: March 2012

Study information

• Verified date: October 2013
• Source: University Hospital Southampton NHS Foundation Trust.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: May 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)

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• geko

• Plaster cast

Locations

Country	Name	City	State
United Kingdom	Southampton University Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	acceptability and tolerance (composite endpoint)	None validated questionnaire and a scoring index to assess comfort of the device	4 hours	No
Primary	Blood flow		4 hours	No
Secondary	microcirculatory blood flow		4 hours	No