Venous Occlusion
Conditions
Keywords
Venous occlusion
Brief 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.
Interventions
DEVICEVenous occlusion (leg tourniquet, made in-house)
Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound
Sponsors
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years old, able to consent
Exclusion criteria
* History of cardiovascular/renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Swelling | 30 minutes | Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous Diameter | 30 minutes | Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trial Cohort All participants | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Trial Cohort | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 1 participants | — |
| Sex/Gender, Customized Male | 1 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Leg Swelling
Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)
Time frame: 30 minutes
Population: Adverse event precluded data collection
Secondary
Venous Diameter
Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm)
Time frame: 30 minutes
Population: Zero analysed due to adverse event during protocol