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Venous Occlusion and Limb Swelling

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ClinicalTrials.gov Identifier: NCT02241343
Recruitment Status : Terminated (Safety concerns)
First Posted : September 16, 2014
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Venous Occlusion Device: Venous occlusion (leg tourniquet, made in-house) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Venous Occlusion and Limb Swelling
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Trial cohort
Measurements taken before and after venous occlusion applied
Device: Venous occlusion (leg tourniquet, made in-house)
Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound




Primary Outcome Measures :
  1. Leg Swelling [ Time Frame: 30 minutes ]
    Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)


Secondary Outcome Measures :
  1. Venous Diameter [ Time Frame: 30 minutes ]
    Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 years old, able to consent

Exclusion Criteria:

  • History of cardiovascular/renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241343


Locations
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United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Alun Davies Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02241343    
Other Study ID Numbers: ICREC 13 6 5
First Posted: September 16, 2014    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Venous occlusion