Condition category
Circulatory System
Date applied
28/12/2013
Date assigned
10/01/2014
Last edited
10/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Graduated elastic compression stockings are the universal treatment option for patients with varicose veins, pain and swelling after a blood clot in the vein and lymphoedema (swelling due to fluid accumulation). However, their effectiveness has never been fully studied. We want to compare the effectiveness of stockings of two different strengths. The results should be able to tell us which stocking is best and how much a stocking improves the blood circulation in veins compared to not wearing stockings.

Who can participate?
Participants include normal volunteers without venous disease and patients with problems related to blood circulation in the veins.

What does the study involve?
You will be asked to complete a short questionnaire. Then you will be requested to lie on an examination couch with your leg exposed and your heel resting on a soft platform. A cuff, like that used for taking a blood pressure, will be placed around your thigh, squeezed and then released. The effect of this mild squeezing of your thigh will be measured using an inflatable air bag wrapped around your calf over the stocking. The calf bag will measure the change in the size of your calf whilst the thigh-cuff is inflated and deflated. This will be performed without a stocking and then with two stockings of different strengths.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However, there should be benefits to future patients who require elastic stockings by customising their strength based on their requirements. There are no risks to taking part in the study. The cuff used to compress the thigh uses less pressure than the cuff used for taking a blood pressure measurement. Care should be taken getting on and off the examination couch and help will be available, if required.

Where is the study run from?
Josef Pflug Vascular Laboratory, Ealing Hospital, UK. All evaluations will be performed in the Josef Pflug Laboratory during a single session.

When is the study starting and how long is it expected to run for?
Recruitment will start in early 2014 and will run for 1 year or until the required number of participants and patients have been recruited and studied.

Who is funding the study?
Bauerfeind AG, Germany.

Who is the main contact?
Mr Christopher R Lattimer
c.lattimer09@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr George Geroulakos

ORCID ID

Contact details

Josef Pflug Vascular Laboratory
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom
g.geroulakos@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS project ID: 143608

Study information

Scientific title

Outflow performance of different stockings in the treatment of chronic venous insufficiency, post-thrombotic syndrome and lymphoedema compared to normal subjects

Acronym

Study hypothesis

Graduated elastic compression stockings improve the venous return compared to no stockings. Our hypothesis is that stronger stockings work better and there may be differences between the patient groups and normal subjects.

Ethics approval

The NRES Committee London - Harrow, 10th December 2013, REC reference, 13/LO/1863.
Final ethical opinion will be confirmed within a maximum of 60 days.

Study design

Interventional, single centre study

Primary study design

Interventional

Secondary study design

Non 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 or lymphatic disease

Intervention

There will be 4 groups of participants, 12 in each group, making a total of 48:

Group 1: Patients with primary varicose veins
Group 2: Patients with the post-thrombotic syndrome
Group 3: Patients with lymphoedema
Group 4: Normal subjects

Each participant will receive 3 interventions applied in random order using sealed envelopes:

1. No intervention
2. Class 1 below-knee stocking (18-21 mmHg)
3. Class 2 below-knee stocking (23-32 mmHg)

These interventions will be tested using an inflatable thigh-cuff to restrict the venous return. The effects of this will be measured using air-plethysmography which records changes in calf volume. Stockings are expected to overcome the restriction of the thigh-cuff by preventing the calf from swelling, and also by a rapid decrease in calf volume on release of the thigh-cuff.

There is no follow-up as part of this study. Patients will have a NHS follow-up as part of their normal NHS care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quantification of calf volume changes as a result of thigh-cuff inflations measured using air-plethysmography. The rate of change of calf volume and the amount of change will be measured at increasing thigh-cuff inflation pressures and after deflation. These outcomes will be measured during a single session lasting about 40 minutes.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2014

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Untreated varicose veins, previous deep venous thrombosis (DVT), lymphoedema or normal controls
2. Leg symptoms (unless a control subject)
3.1 Great saphenous reflux > 0.5 sec
3.2. Reflux > 1 sec and/or obstruction in deep veins on duplex
3.3. Confirmation of lymphoedema by lymphoscintigraphy
4. Agile and able to get on and off an examination couch
5. Ability to comprehend study demands

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Acute DVT within the last 3 months
2. Previous surgery/sclerotherapy for varicose veins
3. Venous ulceration over 2 cm in diameter
4. Gross pitting oedema of the ankle or calf
5. Pregnancy
6. Peripheral vascular disease [Ankle brachial pressure index (ABPI) < 0.9]
7. Cardiac failure
8. Breathlessness after mild exertion
9. Arthritis with significant impairment of mobility
10. Age less than 18 years

Recruitment start date

01/02/2014

Recruitment end date

31/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Josef Pflug Vascular Laboratory
Middlesex
UB1 3HW
United Kingdom

Sponsor information

Organisation

Ealing Hospital NHS Trust (UK)

Sponsor details

Research and Development
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom
eht.researchdevelopmentmanager@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Bauerfeind AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes