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?
Participants will be asked to complete a short questionnaire. Participants are 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 customizing 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)
When is the study starting and how long is it expected to run for?
February 2014 to February 2015
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
020 8967 5000
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 measure
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 (if study stopped)
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
Ealing Hospital
Uxbridge Road
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
020 8967 5000
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
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27161999 (added 22/01/2019)