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Trial registered on ANZCTR
Registration number
ACTRN12608000620325
Ethics application status
Approved
Date submitted
29/09/2008
Date registered
8/12/2008
Date last updated
8/12/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of Sigvaris below-knee light graduated compression stockings on lower limb venous blood flow in seated adults
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Scientific title
The effect of Sigvaris below-knee light graduated compression stockings on lower limb venous blood flow in seated adults
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lower limb venous blood flow
3768
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Condition category
Condition code
Blood
3943
3943
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The effect of below knee graduated compression stockings in adults with normal circulation on venous volume flow after 10 minutes in each of the positions of lying supine, sitting and standing upright
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Intervention code [1]
3591
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Treatment: Devices
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Comparator / control treatment
Randomised controlled trial, crossover design. Control group is measurements of venous flow in the same leg but without the stocking on.
Each participant had a 10-15 minute washout period (from any prior physical activity) on arrival. All participants are asked not to under-take any strenuous activity on the day of their ultrasound scan, such as running or cycling. There is no wash-out period for the crossover between the two interventions of wearing the stocking and not wearing the stocking as this is not considered necessary.
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Control group
Active
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Outcomes
Primary outcome [1]
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Peak venous flow (cm/sec) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the sitting position. The outcome will be assessed with and without the stocking on.
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Assessment method [1]
4841
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Timepoint [1]
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10 minutes
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Secondary outcome [1]
8173
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Mean venous flow (cm/sec) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the sitting position. The outcome will be assessed with and without the stocking on.
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Assessment method [1]
8173
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Timepoint [1]
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10 minutes
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Secondary outcome [2]
8174
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Peak venous flow (cm/sec) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the lying supine position. The outcome will be assessed with and without the stocking on.
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Assessment method [2]
8174
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Timepoint [2]
8174
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10 minutes
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Secondary outcome [3]
8175
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Peak venous flow (cm/sec) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the standing upright position. The outcome will be assessed with and without the stocking on.
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Assessment method [3]
8175
0
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Timepoint [3]
8175
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10 minutes
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Secondary outcome [4]
8176
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Mean venous flow (cm/sec) as measured on Duplex dopller ultrasound scan in the superfical femoral vein in the left leg in the lying supine position. The outcome will be assessed with and without the stocking on.
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Assessment method [4]
8176
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Timepoint [4]
8176
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10 minutes
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Secondary outcome [5]
8177
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Mean venous flow (cm/sec) as measured on Duplex dopller ultrasound scan in the superfical femoral vein in the left leg in the standing upright position. The outcome will be assessed with and without the stocking on.
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Assessment method [5]
8177
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Timepoint [5]
8177
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10 minutes
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Secondary outcome [6]
8178
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Total volume flow (l/min) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the sitting position. The outcome will be assessed with and without the stocking on.
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Assessment method [6]
8178
0
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Timepoint [6]
8178
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10 minutes
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Secondary outcome [7]
8179
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Total volume flow (l/min) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the lying supine position. The outcome will be assessed with and without the stocking on.
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Assessment method [7]
8179
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Timepoint [7]
8179
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10 minutes
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Secondary outcome [8]
8180
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Total volume flow (l/min) as measured on Duplex doppler ultrasound scan in the superfical femoral vein in the left leg in the standing upright position. The outcome will be assessed with and without the stocking on.
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Assessment method [8]
8180
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Timepoint [8]
8180
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10 minutes
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Eligibility
Key inclusion criteria
Able to provide informed consent
Ages between 18 to 65 years.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
History of current or previous deep vein thrombosis
History of current or previous significant peripheral circulation impairment, such as peripheral artherosclerosis, lymphoedema, congestive cardiac failure, or vasculitis.
Evidence on physical examination of perpheral vascular compromise.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
18 healthy adult volunteers enrolled. All volunteers given detailed explanation of the trial and written informed consent obtained. Information on basic demographics and height/weight recorded, and eligibility criteria checked, including a brief physical examination of the lower limb to ensure no circulatory compromise.
Eligible volunteers then get calf circumferance and ankle circumferance and knee to ankle length measurements taken by researchers, as a "fitting" for the appropriate sized stocking, which are then requested from the manufactor (Sigvaris). 6-10 weeks later, allowing time for stockings to arrive, the study participants get an appointment for their ultrasound scanning time. Each participant has their left leg scanned for venous blood flow rates in the superfical femoral vein in the lying supine, sitting at 90 degrees and standing upright positions (in this order) after 10 minutes in each position, both with and without the graduated compression stocking on. The order as to whether the participant is scanned with the stocking on first, or the stocking off first, is determined by the random allocation code. The researcher who determines if the participant is eligible for the study is not aware of the order of the randomisation code at enrollment. The randomisation code is generated by a second researcher after the initial enrollment process has taken place.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequenced generation of an order randomisation code
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1239
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New Zealand
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State/province [1]
1239
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Country [2]
1240
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New Zealand
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State/province [2]
1240
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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GANZONI & Cie Ag
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Address [1]
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GANZONI & Cie AG
Gr blistrasse, 8
CH-9014 St. Gallen
Switzerland
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Country [1]
3940
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Switzerland
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Funding source category [2]
4258
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Commercial sector/Industry
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Name [2]
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GANZONI & Cie Ag
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Address [2]
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GANZONI & Cie AG
Gr?blistrasse, 8
CH-9014 St. Gallen
Switzerland
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Country [2]
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Switzerland
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Primary sponsor type
Commercial sector/Industry
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Name
GANZONI & Cie Ag
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Address
GANZONI & Cie AG
Gröblistrasse, 8
CH-9014 St. Gallen
Switzerland
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Country
Switzerland
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Medical Reasearch Institute of New Zealand
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Address [1]
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Level 3
99 The Terrace
Wellington 6011
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Country [1]
3534
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New Zealand
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Secondary sponsor category [2]
3831
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Other
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Name [2]
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The Medical Research Institute of New Zealand
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Address [2]
3831
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The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
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Country [2]
3831
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6007
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Central Ethics Committee
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Ethics committee address [1]
6007
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PO Box 5013
Wellington 6011
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Ethics committee country [1]
6007
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New Zealand
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Date submitted for ethics approval [1]
6007
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Approval date [1]
6007
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Ethics approval number [1]
6007
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Ethics committee name [2]
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Central ethics commitee, New Zealand
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Ethics committee address [2]
6309
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1-3 The Terrace
PO Box 5013
Wellington
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Ethics committee country [2]
6309
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New Zealand
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Date submitted for ethics approval [2]
6309
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Approval date [2]
6309
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17/03/2008
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Ethics approval number [2]
6309
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Summary
Brief summary
Prolonged seated immobility at work and with long distance air travel is now recognised to be associated with an increased risk of deep vein thormbosis (DVT) through a reduction in lower limb venous blood flow. Graduated compression stockings represent the preferred approach to improve lower limb venous blood flow, thereby reducing the risk of DVT associated with seating seated during long distance travel or whilst at work. The effect of Sigvaris below-knee light graduated compression stockings on lower limb venous blood flow when subjects are stationary in different positions is unknown. In particular, it is uncertain if the stockings have a direct ability to increase venous blood velocity (speed) in the seated position. If it's use is shown to have a direct effect on the venous blood flow in seated subjects, compared to without a stocking, then it would be reasonable to assume that the associated risk of DVT would be reduced.
Study hypothesis: that Sigvaris below knee light graduated compression stockings increase venous blood velocity recordings in the deep vein system of the lower limb (the superfical femoral vein is a deep vein) when assessed on Duplex doppler ultrasound scanning, compared with not wearing a stocking.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Professor Richard Beasley
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Address
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The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
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Country
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New Zealand
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Phone
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+64 4 472 9199
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Fax
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+64 4 472 9224
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Richard Beasley
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Address
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The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
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Country
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New Zealand
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Phone
3071
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+64 4 472 9199
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Fax
3071
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+64 4 472 9224
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Email
3071
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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