Venous OcclusionNCT02241343
Venous Occlusion and Limb Swelling
A study testing Venous occlusion (leg tourniquet, made in-house) in people with Venous Occlusion, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Problems affecting the veins in the legs can cause discomfort and swelling. We want to see how artificially and reversibly blocking the leg veins affects swelling in the lower limb. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Occlusion
- What is being tested?
- Venous occlusion (leg tourniquet, made in-house)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old, able to consent
Who cannot join
- History of cardiovascular/renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Problems affecting the veins in the legs can cause discomfort and swelling. We want to see how artificially and reversibly blocking the leg veins affects swelling in the lower limb.
- Conditions
- Venous Occlusion
- Being tested
- Venous occlusion (leg tourniquet, made in-house)
- Keywords
- Venous occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous occlusion (leg tourniquet, made in-house)Device
Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Trial cohort | Other | Measurements taken before and after venous occlusion applied Receives: Device: Venous occlusion (leg tourniquet, made in-house) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Swelling
Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)
Measured: 30 minutes
Secondary outcomes (1)
Venous Diameter
Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionJun 2014
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous OcclusionStudies of the same condition, open and under way.
- More trials run by Imperial College 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241343
- Sponsor's protocol ID
- ICREC 13 6 5
- Status last verified
- Nov 2020
- First submitted
- 5 Aug 2014
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Occlusion and Limb Swelling
- ClinicalTrials.gov ID
- NCT02241343
- Acronym / sponsor ID
- ICREC 13 6 5
- Conditions
- Venous Occlusion
- Keywords
- Venous occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Problems affecting the veins in the legs can cause discomfort and swelling. We want to see how artificially and reversibly blocking the leg veins affects swelling in the lower limb.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial cohort | Other | Device: Venous occlusion (leg tourniquet, made in-house)Measurements taken before and after venous occlusion applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years old, able to consent
Key exclusion criteria (1 listed)
- History of cardiovascular/renal disease
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 |
|---|---|---|
| Venous occlusion (leg tourniquet, made in-house)Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound | Device | Trial cohort |
Primary outcome
Leg Swelling
Time frame: 30 minutes
Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)
1 secondary outcome
Venous Diameter
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alun Davies principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous occlusion (leg tourniquet, made in-house) in people with Venous Occlusion, run by Imperial College 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Leg Swelling (time frame: 30 minutes). 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 24 Nov 2020.