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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Firstkind Ltd
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd
ClinicalTrials.gov Identifier:
NCT01935414
First received: August 28, 2013
Last updated: June 5, 2014
Last verified: June 2014

August 28, 2013
June 5, 2014
August 2013
June 2014   (final data collection date for primary outcome measure)
Presence of asymptomatic DVT assessed by Duplex Ultrasound [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01935414 on ClinicalTrials.gov Archive Site
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Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
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

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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June 2014   (final data collection date for primary outcome measure)

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) 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

  11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
  12. Long term steroid with dermatological changes
  13. A pulse rate of less than 40 beats/minute
  14. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
  15. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
  16. Participation in any clinical study during the eight (8) weeks preceding the screening period
Both
18 Years and older
No
Contact: Matthew Womack, PhD +44(0) 7456427910 matthew.womack@firstkindmedical.com
United Kingdom
 
NCT01935414
FKD-TEDS-001
No
Firstkind Ltd
Firstkind Ltd
Not Provided
Not Provided
Firstkind Ltd
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP