NCT02241343

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

Same day

First QC Date

August 5, 2014

Results QC Date

October 5, 2020

Last Update Submit

November 2, 2020

Conditions

Venous Occlusion

Keywords

Venous occlusion

Outcome Measures

Primary Outcomes (1)

  • Leg Swelling

    Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)

    30 minutes

Secondary Outcomes (1)

  • Venous Diameter

    30 minutes

Study Arms (1)

Trial cohort

OTHER

Measurements taken before and after venous occlusion applied

Device: Venous occlusion (leg tourniquet, made in-house)

Interventions

Venous occlusion (leg tourniquet, made in-house)DEVICE

Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound

Trial cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old, able to consent

You may not qualify if:

  • History of cardiovascular/renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Results Point of Contact

Title
Miss Kate Williams
Organization
Imperial College London
k.williams@imperial.ac.uk

Study Officials

  • Alun Davies

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

September 16, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

November 24, 2020

Results First Posted

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)