NCT01935414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2016

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

August 28, 2013

Last Update Submit

August 4, 2022

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Presence of asymptomatic DVT assessed by Duplex Ultrasound

    6 weeks

Study Arms (2)

geko™

EXPERIMENTAL

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.

TEDS stockings

ACTIVE COMPARATOR

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.

Interventions

geko™ post-surgery for 48hrs then 4hrs/day until discharge.DEVICE
geko™
TEDS post-surgery for 48hrs then 4hrs/day until discharge.DEVICE
TEDS stockings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMI The Harbour Hospital

Poole, Dorset, BH15 2BH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 5, 2013

Study Start

August 1, 2013

Primary Completion

November 16, 2016

Study Completion

November 16, 2016

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

GB(1)