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Contact Information:

Mr Leon Jonker
+44 (0)176 824 5975
leon.jonker@cumbria.nhs.uk


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Be Part of Research - Trial Details - A multicentre randomised research trial assessing the effectiveness and acceptability of a calf muscle exercise device for supportive treatment of venous leg ulcers
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A multicentre randomised research trial assessing the effectiveness and acceptability of a calf muscle exercise device for supportive treatment of venous leg ulcers

Not Recruiting

Open to: All Genders

Age: Adult

Carlisle Carlisle Carlisle

Medical Conditions

Specialty: Dermatology, Primary sub-specialty: Dermatology
UKCRC code/ Disease: Cardiovascular/ Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified

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.


A venous leg ulcer (VLU) is a long-lasting open sore on the lower leg caused by increased pressure of blood in the leg veins. They are the most common type of leg ulcers, affecting 1-3% of the population over 60 years and this incidence is expected to increase with an aging population. There is some evidence to suggest that specific exercise of the calf muscle through for example plantar flexion movement with resistance (moving the front of the foot up and down, similar to what a drummer does when using the foot pedal of a drum) may improve the calf muscle pump function. This type of exercise has been shown to improve blood flow and endurance, at least in the short term. It is known that the return of blood to the heart from the legs (venous return) depends on an efficient calf muscle pump and adequate range of ankle motion. Whilst failure of these systems may contribute to the development of VLU, evidence suggests that exercise programmes designed to increase the strength of the calf muscle pump through resistance training would be feasible and effective in improving calf muscle pump function and ankle range of motion. However there is still a lot of uncertainty regarding the effects of this exercise on ulcer healing. The aim of this study is to find out whether it would be feasible to run a full scale study looking at the effectiveness of a plantar flexion pedal (developed by StepIt Ltd) will be of benefit to people with VLU in terms of improving the healing rate.

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:

30 May 2017 31 Aug 2020

Publications

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31238798/ results (added 07/09/2020)

Participants are randomly allocated to one of two groups. Those in the first group receive usual treatment only, which involves compression therapy (wearing tight stockings which squeeze the leg to improve circulation). Those in the second group receive usual treatment with the addition of the StepIt exercise programme for 12 weeks. Participants are be supplied with a pedal to use at home and are asked to exercise on the pedal for one minute, followed by a one minute rest, repeated 10 times twice a day. The pace of the StepIt device is variable, but the desired tempo for this study would be a two second downwards and two second upwards motion, if achievable, by the participant. The resistance is approximately 6 kg when pushing downwards. Participants are asked to keep a diary recording how they use the pedal. At the start of the study and after 12 weeks, participants have their VLUs examined and complete assessments and questionnaires to see if their symptoms have improved. The number of participants who take part and remain in the study until the end are also recorded to see if a larger study would be possible.


Adult who have had a VLU for up to six months.

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 VLU


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

  • Cumberland Infirmary
    Newtown Road
    Carlisle
    CA2 7HY
  • Carleton Clinic
    District Nursing Department and R&D Department Cumwhinton Drive
    Carlisle
    CA1 3SX
  • Spencer House GP practice
    St Paul’s Square
    Carlisle
    CA1 1DG

Participants who use the StepIt device may benefit from improved VLU healing, however this has not yet been proven and established, and so there may be no benefit involved with taking part. There are no notable risks involved with taking part.

Mr Leon Jonker
+44 (0)176 824 5975
leon.jonker@cumbria.nhs.uk



The study is sponsored by Cumbria Partnership NHS Foundation Trust and funded by StepIt System AB.



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Read full details for Trial ID: ISRCTN75319519
Last updated 24 August 2022

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