Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1200 participants
INTERVENTIONAL
2023-07-06
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
NCT01573169
A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT
NCT00789542
Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy
NCT06034847
Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
NCT05719688
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion
NCT06221371
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
geko™ T-3 interventional
The geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
geko™ device
Neuromuscular electrical stimulation of the peroneal nerve
Intermittent Pneumatic Compression (IPC)
Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
geko™ device
Neuromuscular electrical stimulation of the peroneal nerve
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical diagnosis of acute stroke (WHO criteria)
3. Within 36 hours of symptom onset
4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person
Exclusion Criteria
2. Unwitnessed onset with a long lie on the floor before admission
3. Clinically apparent deep vein thrombosis at screening
4. Patient is expected to require palliative care within 14 days
5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
6. Patient has recently been involved in or is currently involved in a clinical trial for either a medical device or medicinal product, within the past 3 months, with the exception: if co-enrolment is not considered to impact adverse events or outcomes in the opinion of the Chief Investigator. (A live document containing a list of approved studies will be included in a reference document made available to all study sites and available upon request)
7. Contraindications for the use of the geko™ device:
* Allergy to hydrogel constituents
8. Contraindications to IPC:
* Severe peripheral vascular disease
* Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
* Severe oedema
* Leg deformities making appropriate fitting impossible
9. Uncontrolled congestive cardiac failure
10. Pregnancy
11. Single or double leg amputations
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
Keele University
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
University of California
OTHER
Bournemouth University
OTHER
Firstkind Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christine Roffe, MD FRCP FESO
Role: PRINCIPAL_INVESTIGATOR
Keele University, University Hospitals of North Midlands NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West Suffolk Hospital
Bury St Edmunds, Suffolk, United Kingdom
Royal United Hospital
Bath, , United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Fairfield General Hospital
Bury, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
Whiston Hospital
Liverpool, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Milton Keynes University Hospital
Milton Keynes, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Yeovil Hospital
Yeovil, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lisa Wood
Role: primary
Catherine Durrant
Role: backup
Telma Costa
Role: backup
Scott Luxmore-Brown
Role: primary
Dhanya Babu
Role: primary
Pamela Bradley
Role: primary
Alex McGovern
Role: primary
Gemma Hector
Role: primary
Sherin Sabu
Role: primary
Coleen Ditchfield
Role: primary
Parvathy Gopi
Role: primary
Con Tibajia
Role: primary
Cheryl Padilla-Harris
Role: primary
Amanda Hedstrom
Role: primary
Reece Doonan
Role: primary
Seethalekshmi Vikramadhithyan
Role: primary
Clare Tibke
Role: backup
Surabhi Saxena
Role: primary
Tegan Taylor
Role: primary
Alfonso Tanate
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Device official website
Prof Roffe, official website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FSK-VTE-001
Identifier Type: -
Identifier Source: org_study_id
ISRCTN11175235
Identifier Type: REGISTRY
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.