Condition category
Circulatory System
Date applied
19/12/2019
Date assigned
24/01/2020
Last edited
24/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Venous insufficiency, which is where the veins are not working effectively to return blood to the heart, and disorders of the lymphatic system, which circulates a fluid called lymph in the body, can result in oedema (swelling caused by fluid build-up). The usual treatment for oedema of the legs is compression therapy to force the fluid back into the circulatory system. Compression stockings can prevent and treat symptoms related to oedema of the legs. However, the effect of the compression stocking is only achieved with frequent use. Some people find compression stockings uncomfortable and difficult to put on. Research has shown that more than half of patients do not use compression stockings frequently enough.
Compression stockings are available in four different compression classes, which indicate different levels of compression pressure. The treatment is effective if the right pressure is maintained. However, studies have shown that Class 2 stockings, which are most commonly used, lose pressure while being worn.
The company PressCise has developed a stocking called Lundatex® stocking to be easy to put on and take off while maintaining its pressure. This study aims to compare Lundatex® stocking with another compression stocking that is already widely used.

Who can participate?
Adults aged 18 years or over with oedema in the leg(s) due to venous insufficiency or lymphatic disease

What does the study involve?
Participants will be randomly allocated to one of two groups: the intervention group or the control group. Participants in the intervention group will receive the Lundatex® stocking Class 2) and the participants in the control group will receive the Actico® UlcerSys stocking kit (Class 3, meaning it provides more pressure than a Class 2 stocking). The participants are instructed to use the compression stocking for 2 weeks.
The study includes two visits to the clinic. At the first visit, the participant fills in a questionnaire regarding background information and their previous experience of compression stockings. The leg circumferences will be measured with a measuring tape and the compression pressure under the stocking will be measured with two sensors. The participant will be instructed in how to take on and off the stocking. At the second visit, after 2 weeks, the participant fills in a second questionnaire regarding experiences of the current stocking and same measurements of leg circumferences and compression pressure will take place. Thereafter, the participation is ended and the participant is allowed to keep the compression stocking for free.

What are the possible benefits and risks of participating?
Treatment with the compression stockings can cause side effects such as tingling and numbness in the toes due to compression and skin redness and/or itching due to hypersensitivity or allergy to the stocking materials. If these, or other unexpected side effects occur, treatment will be stopped. However, these side effects are considered minor and no more serious medical risk is considered to exist. Side effects will be recorded in an adverse event report.

Where is the study run from?
South Älvsborg Hospital (Sweden)

Who is funding the study?
VINNOVA (Sweden) and Research Council South Älvsborg (Sweden)

When is the study starting and how long is it expected to run for?
January 2018 to December 2020

Who is the main contact?
Ulrika Källman, ulrika.kallman@vgregion.se

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ulrika Källman

ORCID ID

http://orcid.org/0000-0002-2975-6827

Contact details

South Älvsborg Hospital
Brämhultsvägen 53
Borås
50281
Sweden
+46 (0)70-0823614
ulrika.kallman@vgregion.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Compression from a patient perspective - evaluation of a new innovative compression stocking with well defined pressure, in a randomized controlled trial

Acronym

Study hypothesis

The purpose of the study is to evaluate the Lundatex® Class 2 compression stocking with regard to oedema reduction in relation to the patient's compliance with treatment, and in relation to treatment with the Compression stocking Actico® UlcerSys.

Research questions:
1. Does treatment with Lundatex® Class 2 compression stocking lead to reduced oedema, equivalent or more, in relation to treatment with Actico® UlcerSys?
2. Does treatment with Lundatex® Class 2 compression stocking lead to equivalent or better compliance than regular compression therapy with Actico® UlcerSys?
3. Does the patient consider the Lundatex® stocking to be equivalent or more comfortable to wear, easier to put on and off, and provide better symptom relief than Actico® UlcerSys?
4. Do Lundatex® and Actico® UlcerSys stockings lose some compression pressure after 2 weeks of use?

Ethics approval

Approved 19/11/2018, Gothenburg County Council Ethics Board (Box 401, 405 30 Göteborg , Sweden; +46 031-786 68 21; registrator@etikprovning.se), ref: Dnr 956-18, T1126-18

Study design

Two-arm prospective randomized non-blinded pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Chronic venous insufficiency (CVI), deep vein thrombosis, lymphedema

Intervention

Intervention: Lundatex® stocking – knee-high compression stocking Class 2 (23-32 mmHg). The stocking is used during the daytime for 2 weeks.

Control: Actico® UlcerSys – knee-high compression stocking kit, Class 3 (33-44 mmHg). Time: The inner stocking is used day and night and the outer stocking in the daytime only. The stockings are used together for 2 weeks.

The participants are randomized to each group: 10 participants to the intervention group and 10 to the control group. Randomization is done using a random formula in Excel.

Intervention type

Device

Phase

Not Applicable

Drug names

1. Lundatex®
2. Actico® UlcerSys

Primary outcome measure

Degree of oedema assessed by measuring the circumference of the lower leg will be measured every 4 cm, with start at a predetermined and well-defined zero point with a specially designed tape measure (Perikit) at baseline and at the end of the 2-week treatment period

Secondary outcome measures

1. Stocking compression pressure at baseline and after 2 weeks measured using two pressure sensors (Picopress®, Microlab, Italy) placed on two defined sites - just above the ankle and above the place where the calf has its largest circumference
2. Participant’s compliance assessed at the end of the 2-week treatment period by asking them how many days they used the stockings
3. Participant’s perceptions of the compression stocking's comfort assessed using a 1-10 scale at the end of the 2-week treatment period
4. Participant’s perceptions of the compression stocking's usefulness assessed using a 1-10 scale at the end of the 2-week treatment period
5. Participant’s perceptions of symptom relief provided by the compression stocking assessed using a 1-10 scale at the end of the 2-week treatment period


Overall trial start date

01/01/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Venous insufficiency of the lower leg and classified as C3-C6 according to the Clinical-Aetiology-Anatomic-Pathophysiologic (CEAP) system or lymphedema
2. Leg circumference between 20 cm and 65 cm at the narrowest and widest places
3. Can tolerate compression therapy
4. Ankle-brachial pressure index (ABPI) >0.8
5. Has given consent to participate in the study
6. Needs compression treatment class 2 or class 3 (23-32 mmHg and 34-46 mmHg, respectively according to the RAL-GZG/ENV standard)
7. Aged 18 years or above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Venous insufficiency classified C1 and C2 according to the Clinical-Aetiology-Anatomic-Pathophysiologic (CEAP) system
2. Arterial insufficiency
3. Ankle-brachial pressure index (ABPI) <0.8
4. Leg circumference less than 20 cm or greater than 65 cm
5. Poor or no tolerance of compression
6. Lipoedema
7. Diabetes
8. Heart failure
9. Other conditions that, in the examiner's opinion, restrict the patient from participating in the study

Recruitment start date

01/10/2019

Recruitment end date

01/09/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

South Älvsborg Hospital
Dermatology Department Brämhultsvägen 53
Boås
50457
Sweden

Sponsor information

Organisation

PressCise AB

Sponsor details

Järnvägsplatsen 1
Herrljunga
52430
Sweden
+46 (0)73-973 95 11
andreas@presscise.com

Sponsor type

Industry

Website

https://www.presscise.com

Funders

Funder type

Government

Funder name

VINNOVA

Alternative name(s)

Swedish Governmental Agency for Innovation Systems

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Sweden

Funder name

Research Council South Älvsborg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results are planned to be published in a peer-reviewed scientific journal.

IPD sharing statement:
The datasets generated during and/or analysed during the study will be available upon request from Ulrika Källman, ulrika.kallman@vgregion.se. Data will be available after accepted peer-reviewed publication.

Intention to publish date

01/10/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/01/2020: Trial's existence confirmed by Regionala Etikprövningsnämnden i Göteborg [Gothenburg Regional Ethics Review Board].