Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000774527
Ethics application status
Not yet submitted
Date submitted
16/06/2015
Date registered
27/07/2015
Date last updated
27/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile sequential pneumatic calf compression for leg swelling study.
Scientific title
Assessment of safety and effect of novel sequential calf compression device (Vekroosan) on venous hemodynamics in patients with chronic venous disease.
Secondary ID [1] 286922 0
Nil
Universal Trial Number (UTN)
U1111-1171-2435
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Venous Insufficiency 295346 0
Condition category
Condition code
Cardiovascular 295612 295612 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The calf compressor device resembles a large blood pressure (BP) cuff. It is made of hypoallergenic polyurethane and has a 30cm x10cm battery casing and pump attached to it. The device wraps around the calf and velcros to itself, much like a BP cuff would. Instead of having only a single inflatable chamber, the device has three chambers arranged one above the other. This allows sequential inflation to promote one way venous flow. The chambers inflate to 80mmHg (can be set lower in case of discomfort with a range of 40-80mmHg), starting with the most distal chamber, then the middle chamber, then the most proximal chamber. They then deflate from the most proximal to most distal. The cycle repeats after 10 seconds of inactivity.

Patients will have the calf compressor placed around their calf and be asked to sit for 20 mins of rest. The device is then turned on and venous peak flow velocity is measured at fours places: external iliac, common femoral, distal superficial femoral and popliteal vein levels. Measurements will be the average of 5 repeated determinations of the peak flow velocity at these points.

Patients will then be asked to continue wearing the device for 1 hour while it is turned on to assess tolerance. Its use should be ceased prior to this time in case of any adverse events, which will be recorded. Pre and post use calf measurements taken around the widest point of the calf are to be recorded to assess for any change in swelling.

Comparison between baseline and post calf compression measurements will be made.

Any adverse events as a result of use of the device will be recorded to help assess safety of the device.
Intervention code [1] 292111 0
Treatment: Devices
Comparator / control treatment
No treatment (prior to use in each patient)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295327 0
Change to venous peak flow velocity from baseline (after 20 minutes of rest with the device on the leg but not activated) to immediately after activation of device using colour spectral doppler.
Timepoint [1] 295327 0
Baseline measurements taken before activation of the device, after 20 minutes of rest.
Post measurements taken immediately following device activation.
Primary outcome [2] 295328 0
Observation for any skin changes or pain response from patient as well as asking the patient "have you had any adverse events while using this device"; "did you have any discomfort or pain from using this device? If so please rate it out of 10" as a method for assessing any problems with device use.
Timepoint [2] 295328 0
Any time after starting treatment up to 1 week post
Secondary outcome [1] 315363 0
Subjective analysis of benefit of compression provided by patients during structured qualitative interview.
Timepoint [1] 315363 0
Immediately after using the device.

Eligibility
Key inclusion criteria
History of varicose veins, chronic venous disease symptoms, or chronic leg swelling associated with previous DVT or recent surgery who are unable or unwilling to utilise calf compression stockings (standard of care).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
With acute deep venous thrombosis, acute pulmonary emboli, leg ulcerations, or any open wound, history of malignancies requiring active chemotherapy, unable to consent or under the age of 18.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2015
Actual
Date of last participant enrolment
Anticipated
10/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9848 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 291480 0
Other
Name [1] 291480 0
Southern Sydney Haematology
Country [1] 291480 0
Australia
Primary sponsor type
Individual
Name
William Alexander
Address
Southern Sydney Haematology
7/1 Derby St
Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 290160 0
None
Name [1] 290160 0
Address [1] 290160 0
Country [1] 290160 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293027 0
South Eastern Sydney Local Health District
Ethics committee address [1] 293027 0
Ethics committee country [1] 293027 0
Australia
Date submitted for ethics approval [1] 293027 0
16/06/2015
Approval date [1] 293027 0
Ethics approval number [1] 293027 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58138 0
Mr William Alexander
Address 58138 0
Southern Sydney Haematology
7/1 Derby St Kogarah NSW 2217
Country 58138 0
Australia
Phone 58138 0
+61 2 4229 9400
Fax 58138 0
Email 58138 0
[email protected]
Contact person for public queries
Name 58139 0
William Alexander
Address 58139 0
Southern Sydney Haematology
7/1 Derby St Kogarah NSW 2217
Country 58139 0
Australia
Phone 58139 0
+61 2 4229 9400
Fax 58139 0
Email 58139 0
[email protected]
Contact person for scientific queries
Name 58140 0
William Alexander
Address 58140 0
Southern Sydney Haematology
7/1 Derby St Kogarah NSW 2217
Country 58140 0
Australia
Phone 58140 0
+61 2 4229 9400
Fax 58140 0
Email 58140 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Improvement noted in peak flow velocity and in cal... [More Details]
Study results articleYes awaiting publication - Journal of Haematology

Documents added automatically
No additional documents have been identified.