Merino Encircle Compression Stockings in patients requiring compression stockings for recurrent lower limb venous ulceration and/or lower limb chronic venous disease.

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.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000577617

Enrollment

Registered

2014-05-29

Start date

2014-09-08

Completion date

2014-09-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

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.

Outcome results