Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000461099
Ethics application status
Approved
Date submitted
31/05/2010
Date registered
4/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Encircle graduated compression stockings on lower limb blood flow in seated adults.
Scientific title
A randomised controlled trial investigating the effect of Encircle below-knee merino graduated compression stockings on lower limb venous haemodynamics in seated adults with normal peripheral circulation.
Secondary ID [1] 251905 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis of deep vein thrombosis 256723 0
Condition category
Condition code
Blood 256882 256882 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A graduated below-knee compression stocking will be worn on one leg for approximately120 minutes by trial participants and lower limb blood flow will be measured by ultrasound at time (T) = 0, T = 30, T= 60 and T = 120 minutes after the participant dresses in the stocking.
Intervention code [1] 255949 0
Treatment: Devices
Comparator / control treatment
No treatment - i.e. no stocking. Lower limb blood flow will also be measured by ultrasound in the other leg of each trial participant; so that each participant is their own control.
Control group
Active

Outcomes
Primary outcome [1] 257756 0
The change in peak venous velocity as asssessed by Doppler ultrasound in the popliteal vein.
Timepoint [1] 257756 0
This will be assessed at baseline and after the trial participants have been seated for a 120 minute period.
Secondary outcome [1] 263140 0
The change in mean venous velocity as asssessed by Doppler ultrasound in the popliteal vein.
Timepoint [1] 263140 0
This will be assessed at baseline and after the trial participants have been seated for a 120 minute period.
Secondary outcome [2] 263141 0
The change in vein diameter as asssessed by Doppler ultrasound in the popliteal vein.
Timepoint [2] 263141 0
This will be assessed at baseline and after the trial participants have been seated for a 120 minute period.
Secondary outcome [3] 263142 0
The change in total volume flow as asssessed by Doppler ultrasound in the popliteal vein.
Timepoint [3] 263142 0
This will be assessed at baseline and after the trial participants have been seated for a 120 minute period.
Secondary outcome [4] 263143 0
The level of compression exterted by the graduated compression stocking at the ankle, mid-calf and below knee, as measured by a Kikuhime Pressure Monitor.
Timepoint [4] 263143 0
This will be assessed at baseline and after the trial participants have been seated for a 120 minute period.

Eligibility
Key inclusion criteria
Participants must be able to provide informed consent for participation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A history of previous or current deep vein thrombosis; 2. Pregnancy; 3. History of previous or current peripheral vascular disease or any other lower limb abnormality that is considered by the study researcher to be inappropriate for the application of a graduated compression stocking; 4. Abnormal clinical examination of the lower limbs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2453 0
New Zealand
State/province [1] 2453 0

Funding & Sponsors
Funding source category [1] 256450 0
Commercial sector/Industry
Name [1] 256450 0
Levana Textiles
Country [1] 256450 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Levana Textiles
Address
14/20 Totara St
Levin 5510
Country
New Zealand
Secondary sponsor category [1] 255758 0
None
Name [1] 255758 0
Address [1] 255758 0
Country [1] 255758 0
Other collaborator category [1] 1312 0
Commercial sector/Industry
Name [1] 1312 0
Locus Research Ltd
Address [1] 1312 0
Studio Mauao, 4a Grove Avenue
Mount Maunganui
Tauranga 3149
Country [1] 1312 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259106 0
Central Regional Ethics Committee
Ethics committee address [1] 259106 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 259106 0
New Zealand
Date submitted for ethics approval [1] 259106 0
Approval date [1] 259106 0
15/01/2010
Ethics approval number [1] 259106 0
CEN/09/11/090

Summary
Brief summary
Prolonged seated immobility is a risk factor for the development of deep vein thrombosis (DVT). Graduated compression stockings represent a non-pharmacological approach in reducing the risk of DVT associated with prolonged seated immobility. The simplicity of their use and their minimal side effects have made them popular in preventative care, both in the hospital post operative setting and amongst travellers. This study plans to investigate the pressure profile and effect on blood flow in the lower legs of a newly developed below the knee graduated compression stocking manufactured using merino wool.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30793 0
Address 30793 0
Country 30793 0
Phone 30793 0
Fax 30793 0
Email 30793 0
Contact person for public queries
Name 14040 0
Thom Charles
Address 14040 0
Medical Research Institute of New Zealand
Level G CSB Building
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country 14040 0
New Zealand
Phone 14040 0
+64 4 8050242
Fax 14040 0
Email 14040 0
thom.charles@mrinz.ac.nz
Contact person for scientific queries
Name 4968 0
Richard Beasley
Address 4968 0
Medical Research Institute of New Zealand
Level G CSB Building
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country 4968 0
New Zealand
Phone 4968 0
+64 4 8050147
Fax 4968 0
Email 4968 0
richard.beasley@mrinz.ac.nz

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
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Documents added automatically
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