Deep Vein ThrombosisEarly Phase 1THRIVE-1NCT01981733
Improving Lower Limb Blood Flow in Healthy Adult Volunteers
A Early Phase 1 study testing geko in people with Deep Vein Thrombosis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb using electrical stimulation. Increases in lower limb blood flow improve venous return and thereby reduce venous stasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- geko
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Apr 2012
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be in good general health and fitness.
- Aged between 18 and 65 years.
- Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound within 48 hours prior to commencement of the each study phase.
- BMI between 18 and 34
- No history or signs of drug abuse (including alcohol), licit or illicit.
- Has not to used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the thirty (30) days preceding the study, and agrees not to use any medications during the course of the study without informing the Research Team.
- Able to understand the Volunteer Information Sheet and signed the written Informed Consent Forms.
- Able and willing to follow the Protocol requirements.
Who cannot join
- Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations.
- History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism).
- Peripheral arterial disease (ABPI < 0.9), varicose veins or lower limb ulceration.
- Musculoskeletal disorders (such as pain during exercise of lower limb).
- Recent surgery (such as abdominal, gynaecological, hip knee replacement).
- Recent trauma to lower limb.
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- Chronic Obesity (BMI Index >34).
- Pregnancy.
- Any Medication judged to be significant by the Principal Investigator (such as anticoagulants, agents with significant vasoactive activity, Oestrogen pill, 'morning-after pill' or HRT).
- Tobacco consumption
- History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, endocrine, neurological, dermatological, rheumatologic, metabolic (including diabetes), psychiatric, haematological (especially in relation to clotting or coagulation), or systemic disease judged to be significant.
- A pulse rate of less than 50 beats/minute, a sitting systolic blood pressure >160 or <80 mmHg and/or a sitting diastolic pressure of >90 or <60 mmHg.
- Any significant illness during the four (4) weeks preceding the screening period of the study.
- Any contraindication to blood sampling.
- Donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation.
- Participation in any clinical study during the 8 weeks preceding the dosing period of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Effects of a Novel Method for Improving Lower Limb Blood Flow in Healthy Adult Volunteers
The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb using electrical stimulation. Increases in lower limb blood flow improve venous return and thereby reduce venous stasis. Since stasis is one of the compounding factors in the development of deep vein thrombosis, the risk of developing thrombosis should theoretically be proportionally reduced. This technique may prove to be a useful tool in preventing and reducing the incidence of deep vein thrombosis in both medical and surgical patients together with passengers undertaking significant duration travel (as travel - related deep vein thrombosis is not exclusively related to flying).
- Conditions
- Deep Vein Thrombosis
- Being tested
- geko
- Keywords
- Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gekoDevice
Also called geko TM
The geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Not described Receives: Device: geko |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood flow and volume, together with microcirculatory velocity were measured
Changes in blood flow and volume, together with microcirculatory velocity were measured using laser Doppler flowmetry (Laser Doppler Perfusion \& Temperature Monitor DRT4; Moor Instruments Ltd, UK) and colour flow duplex ultrasound (Philips IU22; Philips Healthcare, USA).
Measured: 30 mins with 10 min washouts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startMar 2005
- Primary completionApr 2012
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.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Tucker, BSc PhD, Principal investigator, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981733
- Sponsor's protocol ID
- THRIVE-1
- Acronym
- THRIVE-1
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Effects of a Novel Method for Improving Lower Limb Blood Flow in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01981733
- Acronym / sponsor ID
- THRIVE-1 / THRIVE-1
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep Vein Thrombosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Apr 2012 (actual)
- First posted
- 11 Nov 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.
The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb using electrical stimulation. Increases in lower limb blood flow improve venous return and thereby reduce venous stasis. Since stasis is one of the compounding factors in the development of deep vein thrombosis, the risk of developing thrombosis should theoretically be proportionally reduced. This technique may prove to be a useful tool in preventing and reducing the incidence of deep vein thrombosis in both medical and surgical patients together with passengers undertaking significant duration travel (as travel - related deep vein thrombosis is not exclusively related to flying).
Study design
- Primary purpose
- Basic science
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: geko |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be in good general health and fitness.
- Aged between 18 and 65 years.
- Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound within 48 hours prior to commencement of the each study phase.
- BMI between 18 and 34
- No history or signs of drug abuse (including alcohol), licit or illicit.
Key exclusion criteria (16 listed)
- Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations.
- History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism).
- Peripheral arterial disease (ABPI < 0.9), varicose veins or lower limb ulceration.
- Musculoskeletal disorders (such as pain during exercise of lower limb).
- Recent surgery (such as abdominal, gynaecological, hip knee replacement).
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 |
|---|---|---|
| gekoAlso: geko TMThe geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve | Device | Device |
Primary outcome
Changes in blood flow and volume, together with microcirculatory velocity were measured
Time frame: 30 mins with 10 min washouts
Changes in blood flow and volume, together with microcirculatory velocity were measured using laser Doppler flowmetry (Laser Doppler Perfusion \& Temperature Monitor DRT4; Moor Instruments Ltd, UK) and colour flow duplex ultrasound (Philips IU22; Philips Healthcare, USA).
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 11 Nov 2013.
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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.
Arthur Tucker, BSc PhD principal investigator
St. Bartholomew's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing geko in people with Deep Vein Thrombosis, run by Queen Mary University of London 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 8 inclusion and 16 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 11 Nov 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in blood flow and volume, together with microcirculatory velocity were measured (time frame: 30 mins with 10 min washouts). 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 11 Nov 2013.