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

ISRCTN ISRCTN45952875
DOI https://doi.org/10.1186/ISRCTN45952875
IRAS number 143608
Secondary identifying numbers IRAS project ID: 143608
Submission date
28/12/2013
Registration date
10/01/2014
Last edited
22/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr George Geroulakos
Scientific

Josef Pflug Vascular Laboratory
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom

Phone 020 8967 5000
Email g.geroulakos@imperial.ac.uk

Study information

Study designInterventional, single centre study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOutflow performance of different stockings in the treatment of chronic venous insufficiency, post-thrombotic syndrome and lymphoedema compared to normal subjects
Study objectivesGraduated 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(s)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.
Health condition(s) or problem(s) studiedChronic venous or lymphatic disease
InterventionThere 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 typeOther
Primary outcome measureQuantification 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 measuresNot provided at time of registration
Overall study start date01/02/2014
Completion date31/01/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants48
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2014
Date of final enrolment31/01/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Josef Pflug Vascular Laboratory
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom

Sponsor information

Ealing Hospital NHS Trust (UK)
Hospital/treatment centre

Research and Development
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
England
United Kingdom

Phone 020 8967 5000
Email eht.researchdevelopmentmanager@nhs.net
ROR logo "ROR" https://ror.org/0380w8h49

Funders

Funder type

Industry

Bauerfeind AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2016 22/01/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

22/01/2019: Publication reference added
11/01/2017: No publications found, verifying study status with principal investigator