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 |
| Integrated Research Application System (IRAS) | 143608 |
| Protocol serial number | IRAS project ID: 143608 |
| Sponsor | Ealing Hospital NHS Trust (UK) |
| Funder | Bauerfeind AG (Germany) |
- 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
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
Scientific
Josef Pflug Vascular Laboratory
Ealing Hospital
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom
| Phone | 020 8967 5000 |
|---|---|
| g.geroulakos@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, single centre study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Outflow performance of different stockings in the treatment of chronic venous insufficiency, post-thrombotic syndrome and lymphoedema compared to normal subjects |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 48 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Uxbridge Road
Middlesex
UB1 3HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/01/2019: Publication reference added
11/01/2017: No publications found, verifying study status with principal investigator
