Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000577617
Ethics application status
Approved
Date submitted
20/05/2014
Date registered
29/05/2014
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Merino Encircle Compression Stockings in patients requiring compression stockings for recurrent lower limb venous ulceration and/or lower limb chronic venous disease.
Scientific title
A study to compare patient satisfaction following the use of Merino Encircle Compression Stockings compared to standard stockings in patients with recurrent lower limb venous ulceration and/or lower limb chronic venous disease.
Secondary ID [1] 284575 0
None
Universal Trial Number (UTN)
U1111-1147-3886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent lower limb venous ulceration 291864 0
lower limb chronic venous disease 291992 0
Condition category
Condition code
Cardiovascular 292215 292215 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Merino Encircle Compression Stocking(s) will be provided for 42 days. These stockings are made of Merino and are below knee. They are avaliable in 3 different compression classes (A1-A3), providing up to 40mmHg compression. Classes will be matched to those provided by participant's previous stockings. They will be asked to don stockings in place of their usual stocking regimen.
Intervention code [1] 289352 0
Treatment: Other
Comparator / control treatment
Stockings used immediately prior to enrolment in the study, for at least 42 days.
Control group
Historical

Outcomes
Primary outcome [1] 292085 0
Subjects’ preferred choice of stocking to wear following completion of the study.
Timepoint [1] 292085 0
Visit 3 (42 days after Visit 1 (enrolment))
Secondary outcome [1] 308183 0
Satisfaction and symptoms: via point scale and free text study questionnaire
Timepoint [1] 308183 0
At baseline, Visit 2 (up to 14 days after Visit 1 (enrolment)) and at Visit 3 (42 days after Visit 1)
Secondary outcome [2] 308184 0
ankle, calf and thigh circumference measurement with measuring tape.
Timepoint [2] 308184 0
At baseline, Visit 2 (up to 14 days after Visit 1 (enrolment)) and at Visit 3 (42 days after Visit 1)
Secondary outcome [3] 308185 0
Ulcer (in patients with an active ulcer), qualitative visual assessment and physical measurement.
Timepoint [3] 308185 0
At baseline, Visit 2 (up to 14 days after Visit 1 (enrolment)) and at Visit 3 (42 days after Visit 1)
Secondary outcome [4] 308186 0
Satisfaction using “nuyarn” merino stocking(s) for up to ten minutes on affected leg(s) at Visit 3. As per questionnaire with point scale. These stokcings are also made of merino and have been woven differently to the standard Merino Encircle Compression stockings used in the rest of the trial.
Timepoint [4] 308186 0
At Visit 3 (42 days after Visit 1 (enrolment))

Eligibility
Key inclusion criteria
1. Current use of lower limb compression stockings with recurrent lower limb venous ulceration and/or lower limb chronic venous disease.
2. Use of the same compression stocking for the previous 42 days (without change of brand or class).
3. Age between 18 and 65 years old.
4. Able to give consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy.
2. Current requirement for a stocking providing over 40mmHg pressure.
3. Lower limb lymphoedema.
4. Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/06/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
Actual
10/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
7
Recruitment outside Australia
Country [1] 6045 0
New Zealand
State/province [1] 6045 0

Funding & Sponsors
Funding source category [1] 289208 0
Commercial sector/Industry
Name [1] 289208 0
Encircle Medical Devices
Country [1] 289208 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Encircle Medical Devices
Address
46 Coleridge St, Sydenham, Christchurch, New Zealand 8023
Country
New Zealand
Secondary sponsor category [1] 287884 0
None
Name [1] 287884 0
N/A
Address [1] 287884 0
N/A
Country [1] 287884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290982 0
Health and Disability Ethics Committees
Ethics committee address [1] 290982 0
PO Box 5013, Wellington, 6011
Ethics committee country [1] 290982 0
New Zealand
Date submitted for ethics approval [1] 290982 0
Approval date [1] 290982 0
16/10/2013
Ethics approval number [1] 290982 0
13/NTB/150

Summary
Brief summary
The aim of this study is to investigate patient satisfaction following the use of Merino Encircle Compression Stocking(s) and to compare them to the stocking(s) they usually use. The study is funded by the Encircle Medical Devices, who manufacture them. The study is run by the Orthotic Centre Wellington and the Medical Research Institute of New Zealand. At least twenty patients will be asked to take part in this study. We are inviting patients currently using below knee compression stockings to take part. Participants will be provided with Merino stockings to wear for six weeks instead of their usual stockings. The study will involve three visits to the Orthotic Centre Wellington. At the first visit we ask general questions about health and provide a questionnaire about symptoms. We will measure leg circumference and fit the Merino Encircle Compression Stocking(s). At visit 2 (within two weeks) we will provide another questionnaire and measure leg circumference. At visit 3 (6 weeks) we provide a questionnaire and measure leg circumference
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 714 714 0 0
/AnzctrAttachments/366300-SUMMARY MERINO STUDY_Unfunded.pdf

Contacts
Principal investigator
Name 48258 0
Prof Richard Beasley
Address 48258 0
Medical Research Institute of New Zealand
PO Box 7902, Wellington, New Zealand 6242
Country 48258 0
New Zealand
Phone 48258 0
+64 4 805 0147
Fax 48258 0
Email 48258 0
[email protected]
Contact person for public queries
Name 48259 0
Dr Janine Pilcher
Address 48259 0
Medical Research Institute of New Zealand
PO Box 7902, Wellington, New Zealand 6242
Country 48259 0
New Zealand
Phone 48259 0
+64 4 805 0147
Fax 48259 0
Email 48259 0
[email protected]
Contact person for scientific queries
Name 48260 0
Dr Janine Pilcher
Address 48260 0
Medical Research Institute of New Zealand
PO Box 7902, Wellington, New Zealand 6242
Country 48260 0
New Zealand
Phone 48260 0
+64 4 805 0147
Fax 48260 0
Email 48260 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.