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

Tracking Information
First Submitted Date ICMJE	August 28, 2013
First Posted Date ICMJE	September 5, 2013
Last Update Posted Date	February 7, 2018
Study Start Date ICMJE	August 2013
Estimated Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 30, 2013)	Presence of asymptomatic DVT assessed by Duplex Ultrasound [ Time Frame: 6 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01935414 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Deep Vein Thrombosis
Intervention ICMJE	Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.; Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.
Study Arms	Experimental: geko™ geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge Intervention: 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 Intervention: Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: August 30, 2013)	40
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 2018
Estimated Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Aged 18 years of age and over; Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).; 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.; Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.; Able and willing to follow the protocol requirements. Exclusion Criteria: Are requiring hip revision surgery; History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.; Evidence of asymptomatic DVT by Duplex Ultrasound; Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.; Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2; Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).; Recent trauma to lower limb.; Chronic Obesity (BMI Index >40kg/m2).; Pregnancy.; Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. 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. VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders; On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin; Long term steroid with dermatological changes; A pulse rate of less than 40 beats/minute; A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.; Any significant illness during the four (4) weeks preceding the hip replacement surgery.; Participation in any clinical study during the eight (8) weeks preceding the screening period
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Matthew Womack, PhD +44(0) 7456427910 matthew.womack@firstkindmedical.com
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01935414
Other Study ID Numbers ICMJE	FKD-TEDS-001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Firstkind Ltd
Study Sponsor ICMJE	Firstkind Ltd
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Firstkind Ltd
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP