Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000495820
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
8/05/2012
Date last updated
8/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison between a micro mobile compression device and below-knee graduated compression stockings on lower limb blood flow
Scientific title
A comparison between the Frogg micro mobile compression device and Mediven Plus below-knee graduated compression stockings on lower limb venous haemo-dynamics in healthy adults
Secondary ID [1] 280117 0
Nil
Universal Trial Number (UTN)
U1111-1129-0800
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis of deep vein thrombosis 286038 0
Condition category
Condition code
Blood 286228 286228 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A non-tethered novel micro mobile compression device built into the sole of a shoe will be worn by seated adults over a 60 minute period. The pressure exerted by a small thrusting pad on the plantar venous plexus equates to 314 mmHg. Only one micro mobile compression device will be worn by each subject, which foot receives the intervention will be randomly allocated. The opposite leg will receive the alternative intervention and will be worn at the same time. The effect of each intervention on the popliteal vein blood flow will be measured on each leg.
Intervention code [1] 284451 0
Treatment: Devices
Intervention code [2] 284815 0
Prevention
Comparator / control treatment
A below knee graduated compression stocking will be worn as an active comparator in the same seated adults, on the leg that has not been allocated the micro mobile compression device, over a 60 minute timeframe. The graduated compression stockings exert between 18-21mmhg of pressure at the ankle.
Control group
Active

Outcomes
Primary outcome [1] 287032 0
Peak systolic velocity (cm/s) in the popliteal vein as determined by doppler ultrasound
Timepoint [1] 287032 0
60 minutes
Secondary outcome [1] 297247 0
Peak systolic velocity (cm/s) in the popliteal vein as determined by doppler ultrasound
Timepoint [1] 297247 0
30 minutes
Secondary outcome [2] 297248 0
Mean flow velocity (cm/s) in the popliteal vein as determined by doppler ultrasound
Timepoint [2] 297248 0
30 and 60 minutes
Secondary outcome [3] 297249 0
Vein area (mm) in the popliteal vein as determined by doppler ultrasound
Timepoint [3] 297249 0
30 and 60 minutes
Secondary outcome [4] 297250 0
Total volume flow (L/s) in the popliteal vein as determined by doppler ultrasound
Timepoint [4] 297250 0
30 and 60 minutes
Secondary outcome [5] 297251 0
Leg circumference (mm) as measured at the level immediately above the lateral maleolus, also at the point of greatest circumference of the calf muscle.
Timepoint [5] 297251 0
60 minutes

Eligibility
Key inclusion criteria
Able to provide informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of previous or current deep vein thrombosis

Pregnancy

History of clinical features of peripheral vascular disease (including arterial and venous insufficiency), or other lower limb abnormalities, such as peripheral neuropathy, scleroderma, lymphoedema, or joint deformity from inflammatory arthritis

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
Recruiting
Date of first participant enrolment
Anticipated
7/05/2012
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] 4200 0
New Zealand
State/province [1] 4200 0
Wellington

Funding & Sponsors
Funding source category [1] 285165 0
Commercial sector/Industry
Name [1] 285165 0
AVEX Health Ltd
Country [1] 285165 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 284081 0
None
Name [1] 284081 0
Address [1] 284081 0
Country [1] 284081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286873 0
Multi Region Ethics Committee
Ethics committee address [1] 286873 0
c/- Ministry of Health
Level 2, Reception
1-3 The Terrace
Wellington 6011
Ethics committee country [1] 286873 0
New Zealand
Date submitted for ethics approval [1] 286873 0
23/11/2011
Approval date [1] 286873 0
16/04/2012
Ethics approval number [1] 286873 0
MEC /11/12/100

Summary
Brief summary
Pneumatic compression devices are commonly used in deep vein thrombosis prevention in the hospital setting, but are often too cumbersome to permit easy ambulation with the device. A novel non-tethered portable mechanical compression device is being compared with a below knee graduated compression stocking, in their relative ability to affect lower limb blood flow in seated healthy adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33902 0
Address 33902 0
Country 33902 0
Phone 33902 0
Fax 33902 0
Email 33902 0
Contact person for public queries
Name 17149 0
Thomas Charles
Address 17149 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17149 0
New Zealand
Phone 17149 0
+64 4 8050242
Fax 17149 0
Email 17149 0
thom.charles@mrinz.ac.nz
Contact person for scientific queries
Name 8077 0
Richard Beasley
Address 8077 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8077 0
New Zealand
Phone 8077 0
+64 4 8050147
Fax 8077 0
Email 8077 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.