FISCU III
Research type
Research Study
Full title
Exploring the feasibility of using an exercise-based, self-managed, lifestyle intervention for venous leg-ulcer prevention in adults with a venous leg-ulcer history (FISCU III).
IRAS ID
254648
Contact name
Markos Klonizakis
Contact email
Sponsor organisation
Sheffield Health and Social Care NHS FT
Duration of Study in the UK
3 years, 10 months, 1 days
Research summary
Venous leg ulcers (VLUs) affect approximately 400,000 U.K. people/year. These are caused by inadequate blood flow through the veins, causing pain and social isolation. Each VLU costs up-to £13.5k/year to the NHS; total costs being about £920 million/year. Compression (bandages/stockings) is used to treat VLUs: although healing rates are good, up-to 69% of ulcers return within 12-months. Supportive therapies to compression are needed to reduce healing times and prevent recurrence. Exercise may be an answer.
We recently completed two small studies, where we worked together with people with VLUs to examine if we could use a 12-week, lifestyle programme based on aerobic exercises, alongside compression, to treat VLUs, either at home or in the community. In both settings, the programme was safe, while participants enjoyed it-attending 88% of all sessions and completing all tests. Having proven that our programme can be used as a supportive treatment therapy, we would like to see if it can also be used as a tool to prevent ulcers from re-appearing.
FISCU-III will last 36 months. We will recruit 60 Sheffield people, who had their VLUs recently healed. Following some tests on flexibility/fitness, quality-of-life and ulcer history, participants will be randomly placed into one-of-two groups: Group-A will follow our programme and have compression for 12-months; Group-B will receive compression only.
The programme will be self-managed, with participants having frequent face-to-fac and telephone contact with our programme facilitators.
Participants will complete four set of tests: at the beginning, and then at 3-,6-and 12-months post-recruitment, in which we will repeat all tests and also collect evidence for potential new ulcers, VLUs-associated costs and number of falls.
We will then talk to participants, nurses and facilitators about their programme experience.
People with VLUs have helped us develop the FISCU programme. Upon completion, we will move to a full-scale study.
REC name
London - South East Research Ethics Committee
REC reference
24/LO/0909
Date of REC Opinion
15 Jan 2025
REC opinion
Further Information Favourable Opinion