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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
Scientific title
The effect of Sigvaris below-knee light graduated compression stockings on lower limb venous blood flow in seated adults
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb venous blood flow 3768 0
Condition category
Condition code
Blood 3943 3943 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 3591 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 4841 0
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.
Timepoint [1] 4841 0
10 minutes
Secondary outcome [1] 8173 0
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.
Timepoint [1] 8173 0
10 minutes
Secondary outcome [2] 8174 0
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.
Timepoint [2] 8174 0
10 minutes
Secondary outcome [3] 8175 0
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.
Timepoint [3] 8175 0
10 minutes
Secondary outcome [4] 8176 0
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.
Timepoint [4] 8176 0
10 minutes
Secondary outcome [5] 8177 0
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.
Timepoint [5] 8177 0
10 minutes
Secondary outcome [6] 8178 0
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.
Timepoint [6] 8178 0
10 minutes
Secondary outcome [7] 8179 0
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.
Timepoint [7] 8179 0
10 minutes
Secondary outcome [8] 8180 0
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.
Timepoint [8] 8180 0
10 minutes

Eligibility
Key inclusion criteria
Able to provide informed consent
Ages between 18 to 65 years.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequenced generation of an order randomisation code
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 1239 0
New Zealand
State/province [1] 1239 0
Country [2] 1240 0
New Zealand
State/province [2] 1240 0

Funding & Sponsors
Funding source category [1] 3940 0
Commercial sector/Industry
Name [1] 3940 0
GANZONI & Cie Ag
Country [1] 3940 0
Switzerland
Funding source category [2] 4258 0
Commercial sector/Industry
Name [2] 4258 0
GANZONI & Cie Ag
Country [2] 4258 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
GANZONI & Cie Ag
Address
GANZONI & Cie AG

Gröblistrasse, 8

CH-9014 St. Gallen
Switzerland
Country
Switzerland
Secondary sponsor category [1] 3534 0
Other Collaborative groups
Name [1] 3534 0
Medical Reasearch Institute of New Zealand
Address [1] 3534 0
Level 3
99 The Terrace
Wellington 6011
Country [1] 3534 0
New Zealand
Secondary sponsor category [2] 3831 0
Other
Name [2] 3831 0
The Medical Research Institute of New Zealand
Address [2] 3831 0
The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
Country [2] 3831 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6007 0
Central Ethics Committee
Ethics committee address [1] 6007 0
PO Box 5013
Wellington 6011
Ethics committee country [1] 6007 0
New Zealand
Date submitted for ethics approval [1] 6007 0
Approval date [1] 6007 0
Ethics approval number [1] 6007 0
Ethics committee name [2] 6309 0
Central ethics commitee, New Zealand
Ethics committee address [2] 6309 0
1-3 The Terrace
PO Box 5013
Wellington
Ethics committee country [2] 6309 0
New Zealand
Date submitted for ethics approval [2] 6309 0
Approval date [2] 6309 0
17/03/2008
Ethics approval number [2] 6309 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28986 0
Address 28986 0
Country 28986 0
Phone 28986 0
Fax 28986 0
Email 28986 0
Contact person for public queries
Name 12143 0
Professor Richard Beasley
Address 12143 0
The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
Country 12143 0
New Zealand
Phone 12143 0
+64 4 472 9199
Fax 12143 0
+64 4 472 9224
Email 12143 0
[email protected]
Contact person for scientific queries
Name 3071 0
Professor Richard Beasley
Address 3071 0
The Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington 6011
Country 3071 0
New Zealand
Phone 3071 0
+64 4 472 9199
Fax 3071 0
+64 4 472 9224
Email 3071 0
[email protected]

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No Supporting Document Provided



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