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Safety concerns
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial cohort | Other | Measurements taken before and after venous occlusion applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous occlusion (leg tourniquet, made in-house) | Device | Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leg Swelling | Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Diameter | Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm) | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alun Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trial Cohort | All participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Trial Cohort | All participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leg Swelling | Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml) | Adverse event precluded data collection | Posted | 30 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trial Cohort | 0 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faint | Investigations | Systematic Assessment | Subject fainted shortly after venous tourniquet applied. Reduction in venous return thought to adversely affect perfusion. Fully recovered after release of tourniquet. No injuries sustained |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Kate Williams | Imperial College London | k.williams@imperial.ac.uk |
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| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Secondary | Venous Diameter | Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm) | Zero analysed due to adverse event during protocol | Posted | 30 minutes |
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| 0 |
| 1 |
| 1 |
| 1 |
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