Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Leon Jonker
+44 (0)176824 5975
leon.jonker@nihr.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - A multi-centre interventional study to determine patient and clinician impression of different compression therapy options for the treatment of poor leg circulation
Back

A multi-centre interventional study to determine patient and clinician impression of different compression therapy options for the treatment of poor leg circulation

Not Recruiting

Open to: All Genders

Age: Adult

Carlisle Carlisle Penrith Aspatria Wigton Carlisle

Medical Conditions

Chronic Venous Insufficiency

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Background and study aims
For patients in whom the circulation of the leg is not optimal, the function of the veins in particular may be managed with compression bandaging. Compression bandaging can assist in improving blood flow and reducing swelling of the legs. This study looks at how comfortable two different brands of short-stretch two-layer compression bandaging are for patients. Patients are asked to record the degree of itchiness and other undesirable effects of wearing compression bandaging. The study is also looking to find out the overall impression of comfort, functionality and compliance with each type of compression bandaging as well as any changes to skin characteristics. A clinician’s opinion on preference of compression bandage type will also be investigated (for example, by asking them how easy it is to apply each type of bandage). The two different compression bandages used in the study are Coban 2 standard and LITE (manufactured by 3M) and CoFlex TLC Calamine standard and LITE (by Andover Healthcare). Each participant will be its own control and will use identical compression levels for each bandage type.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Dec 2018 30 Nov 2019

Publications

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32501761/ results (added 08/06/2020)

Participants complete a number of questionnaires at week 0 (start of study), week 3 and week 6. All questions are in relation to the patient's leg condition and itchiness that may be caused by wearing a compression bandage on the leg. At week 0 they are randomly allocated to one of two treatment groups, either Coban2 Lite or CoFlex TLC calamine Lite compression bandage, and they wear one of the two for the first 3 weeks. Patients switch over to the other bandage at week 3 and wear the second brand of bandage for the second 3 weeks (up to week 6). The only difference is whether they start with Coban2 or CoFlex bandaging. At week 4 and 8, the research team conduct a follow-up appointment to complete an experience questionnaire and leg and skin characteristics are evaluated. After the 6 week trial period, clinical staff recommence managing the leg – in terms of compression bandage choice - as per routine care.

What are the possible benefits and risks of participating?
Apart from a change in the brand of compression bandage used, the treatment received will not differ from standard treatment and hence the risks are very low. This means that if patients do not take part in the study, then most likely they will be prescribed one of the compression bandage types as part of their normal regular care. Because this study will not significantly affect standard treatment, there is no anticipated immediate benefit expected. However, there is a chance that one of the two bandages that are studied may be more comfortable to wear. At present this is not known and the study is designed to find out if this is the case. As with all compression bandages, there is a risk of damage to the leg if it is not applied properly, and the products used may be irritating to wear for some patients. The study is aimed to investigate how two different compression bandages perform on that front. Participants will not be seen more often by clinical staff , and if clinically indicated the compression bandage may be discontinued or a referral to a specialist may be indicated (again, this is no different from normal clinical practice).

Where is the study run from?
Cumbria Partnership NHS Foundation Trust, North Cumbria University Hospitals NHS, and GP practices in North Cumbria CCG NHS (UK)

When is the study starting and how long is it expected to run for?
December 2018 to November 2019

Who is funding the study?
Andover Healthcare Inc, based in the United States, has provided a non-restricted research grant to fund this project. This means that, although external funding has been received, the results of the study will be reported on and published by the NHS research team without interference from the grant provider. The study team will anonymise the data and it will then be analysed, again by Cumbria Partnership staff. None of the staff at Cumbria Partnership has any conflicts of interest with the company providing the compression bandages.

Who is the main contact?
Dr Stacey Fisher
stacey.fisher@cumbria.nhs.uk


_____
Previous plain English summary:
Background and study aims
For patients in whom the circulation of the leg is not optimal, the function of the veins in particular may be managed with compression bandaging. Compression bandaging can assist in improving blood flow and reducing swelling of the legs. This study looks at how comfortable two different brands of short-stretch two-layer compression bandaging are for patients. Patients are asked to record the degree of itchiness and other undesirable effects of wearing compression bandaging. The study is also looking to find out the overall impression of comfort, functionality and compliance with each type of compression bandaging as well as any changes to skin characteristics. A clinician’s opinion on preference of compression bandage type will also be investigated (for example, by asking them how easy it is to apply each type of bandage). The two different compression bandages used in the study are Coban 2 LITE (manufactured by 3M) and CoFlex TLC Calamine LITE (by Andover Healthcare).

Who can participate?
Patients aged over 18 who have chronic venous insufficiency (poor blood circulation in the legs) and who would benefit from compression bandaging to control swelling and/or promote healing of any skin damage (including ulcers)

What does the study involve?
Participants complete a number of questionnaires at week 0 (start of study), week 4 and week 8. All questions are in relation to the patient's leg condition and itchiness that may be caused by wearing a compression bandage on the leg. At week 0 they are randomly allocated to one of two treatment groups, either Coban2 Lite or CoFlex TLC calamine Lite compression bandage, and they wear one of the two for the first 4 weeks. Patients switch over to the other bandage at week 4 and wear the second brand of bandage for the second 4 weeks (up to week 8). The only difference is whether they start with Coban2 or CoFlex bandaging. At week 4 and 8, the research team conduct a follow-up appointment to complete an experience questionnaire and leg and skin characteristics are evaluated. After the 8 week trial period, clinical staff recommence managing the leg – in terms of compression bandage choice - as per routine care.


Patients aged over 18 who have chronic venous insufficiency (poor blood circulation in the legs) and who would benefit from compression bandaging to control swelling and/or promote healing of any skin damage (including ulcers)
Patients aged over 18 who have chronic venous insufficiency (poor blood circulation in the legs) and who would benefit from compression bandaging to control swelling and/or promote healing of any skin damage (including ulcers)

You can take part if:



You may not be able to take part if:


1. Under the age of 18 years2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity3. Limited life expectancy, i.e. undergoing palliative care4. Active infection in the leg, incl infected venous leg ulcer, cellulitis or otherwise, that requires systematic antibiotic treatment – or within 1 one week of completing antibiotics course. This includes prophylactic antibiotic use5. Patients who are participating in another research study involving an investigational product that is related to leg, skin, or a co-morbidity that may influence the function of compression bandaging6. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives7. Ankle brachial index < 0.5, measured within 12 months of baseline visit or at baseline of trial participation8. Any condition that is contraindicated for the use of any of the compression bandaging used in this trial (including ZnO, Calamine)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cumbria Partnership NHS Foundation Trust
    Carleton Clinic, R&D department Cumwhinton Drive
    Carlisle
    CA1 3SX
  • Carlisle Healthcare
    St Paul’s Square
    Carlisle
    CA1 1DG
  • Temple Sowerby Medical Practice
    Temple Sowerby
    Penrith
    CA10 1RW
  • Aspatria Medical Group
    Aspatria
    CA7 3HH
  • Wigton Group Medical Practice
    Wigton
    CA7 9QD
  • North Cumbria University Hospitals NHS Trust
    Cumberland Infirmary Newtown Road
    Carlisle
    CA2 7HY

Apart from a change in the brand of compression bandage used, the treatment received will not differ from standard treatment and hence the risks are very low. This means that if patients do not take part in the study, then most likely they will be prescribed one of the compression bandage types as part of their normal regular care. Because this study will not significantly affect standard treatment, there is no anticipated immediate benefit expected. However, there is a chance that one of the two bandages that are studied may be more comfortable to wear. At present this is not known and the study is designed to find out if this is the case. As with all compression bandages, there is a risk of damage to the leg if it is not applied properly, and the products used may be irritating to wear for some patients. The study is aimed to investigate how two different compression bandages perform on that front. Participants will not be seen more often by clinical staff , and if clinically indicated the compression bandage may be discontinued or a referral to a specialist may be indicated (again, this is no different from normal clinical practice).
Apart from a change in the brand of compression bandage used, the treatment received will not differ from standard treatment and hence the risks are very low. This means that if patients do not take part in the study, then most likely they will be prescribed one of the compression bandage types as part of their normal regular care. Because this study will not significantly affect standard treatment, there is no anticipated immediate benefit expected. However, there is a chance that one of the two bandages that are studied may be more comfortable to wear. At present this is not known and the study is designed to find out if this is the case. As with all compression bandages, there is a risk of damage to the leg if it is not applied properly, and the products used may be irritating to wear for some patients. The study is aimed to investigate how two different compression bandages perform on that front. Participants will not be seen more often by clinical staff , and if clinically indicated the compression bandage may be discontinued or a referral to a specialist may be indicated (again, this is no different from normal clinical practice).

Dr Leon Jonker
+44 (0)176824 5975
leon.jonker@nihr.ac.uk



The study is sponsored by Cumbria Partnership NHS Foundation Trust and funded by Andover Healthcare, Inc..



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN95282887

Or CPMS 40144

Last updated 08 June 2020

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top