Deep Vein ThrombosisNCT01935414
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
A study testing geko™ post-surgery for 48hrs then 4hrs/day until discharge. and TEDS post-surgery for 48hrs then 4hrs/day until discharge. in people with Deep Vein Thrombosis, run by Firstkind Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- geko™ post-surgery for 48hrs then 4hrs/day until discharge. and TEDS post-surgery for 48hrs then 4hrs/day until discharge.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to 16 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- geko™ post-surgery for 48hrs then 4hrs/day until discharge., TEDS post-surgery for 48hrs then 4hrs/day until discharge.
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™ post-surgery for 48hrs then 4hrs/day until discharge.Device
TEDS post-surgery for 48hrs then 4hrs/day until discharge.Device
| Study group | Role | What they receive |
|---|---|---|
| geko™ | Experimental | geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge Receives: 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 Receives: Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of asymptomatic DVT assessed by Duplex Ultrasound
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935414
- Sponsor's protocol ID
- FKD-TEDS-001
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2013
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01935414
- Acronym / sponsor ID
- FKD-TEDS-001
- Conditions
- Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| geko™ | Experimental | Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge |
| TEDS stockings | Active comparator | Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Presence of asymptomatic DVT assessed by Duplex Ultrasound
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko™ post-surgery for 48hrs then 4hrs/day until discharge. and TEDS post-surgery for 48hrs then 4hrs/day until discharge. in people with Deep Vein Thrombosis, run by Firstkind Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of asymptomatic DVT assessed by Duplex Ultrasound (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.