Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
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ClinicalTrials.gov Identifier: NCT01935414 |
Recruitment Status
:
Recruiting
First Posted
: September 5, 2013
Last Update Posted
: February 7, 2018
|
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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. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 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 |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | June 2018 |
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. |
- Presence of asymptomatic DVT assessed by Duplex Ultrasound [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935414
Contact: Matthew Womack, PhD | +44(0) 7456427910 | matthew.womack@firstkindmedical.com |
United Kingdom | |
BMI The Harbour Hospital | Recruiting |
Poole, Dorset, United Kingdom, BH15 2BH |
Additional Information:
Responsible Party: | Firstkind Ltd |
ClinicalTrials.gov Identifier: | NCT01935414 History of Changes |
Other Study ID Numbers: |
FKD-TEDS-001 |
First Posted: | September 5, 2013 Key Record Dates |
Last Update Posted: | February 7, 2018 |
Last Verified: | February 2018 |
Additional relevant MeSH terms:
Thrombosis Thromboembolism Venous Thrombosis |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |