Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

• Sponsor: Firstkind Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01935414
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 39.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis	Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.; Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multicentre Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between the gekoTM Device and Thromboembolism Deterrent Stockings in Patients Recovering From Total Hip Replacement Surgery
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Nov 16, 2016
• Actual Study Completion Date: Nov 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: geko™ geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge	Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.
Active Comparator: TEDS stockings TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge	Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.

Outcome Measures

Primary Outcome Measures

1. Presence of asymptomatic DVT assessed by Duplex Ultrasound [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Aged 18 years of age and over

2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).

3. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.

4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.

5. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Are requiring hip revision surgery

2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.

3. Evidence of asymptomatic DVT by Duplex Ultrasound

4. Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.

5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2

6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).

7. Recent trauma to lower limb.

8. Chronic Obesity (BMI Index >40kg/m2).

9. Pregnancy.

10. Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months)

1. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.

2. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders

1. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin

2. Long term steroid with dermatological changes

3. A pulse rate of less than 40 beats/minute

4. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.

5. Any significant illness during the four (4) weeks preceding the hip replacement surgery.

6. Participation in any clinical study during the eight (8) weeks preceding the screening period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BMI The Harbour Hospital	Poole	Dorset	United Kingdom	BH15 2BH

Sponsors and Collaborators

• Firstkind Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Company website

Publications

None provided.

• Responsible Party: Firstkind Ltd
• ClinicalTrials.gov Identifier: NCT01935414
• Other Study ID Numbers: FKD-TEDS-001
• First Posted: Sep 5, 2013
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Thrombosis; Thromboembolism; Venous Thrombosis

Study Results

No Results Posted as of Aug 5, 2022