PURE Pilot Study Version 3.0
Research type
Research Study
Full title
A Pilot study to evaluate the feasibility and acceptibility of exercise in the Prevention of leg Ulcer Recurrence (P-PURE)
IRAS ID
312420
Contact name
Alun Davies
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Venous leg ulcers (VLU) and functional ulcers (FU) (collectively known as ‘leg ulcers’ [LUs]) are common conditions. Caused by the poor blood flow through the veins back to the heart, they can have a negative impact on a patient’s wellbeing, causing pain, sleep disruption and poor mobility. LUs are also expensive to treat, costing the NHS approximately £3.2 billion each year.
Treatments to encourage the healing of LUs include compression therapy (e.g. stockings) which squeeze the leg and improve the flow of blood, and surgery to correct the poor blood flow in the case of VLUs. Once a LU has healed, patients are advised to wear compression stockings to prevent the LU from coming back. Many patients struggle to continue wearing compression stockings and as many as 70% of LUs return within 1 year.
NICE advises that extra treatments, such as exercise and lifestyle advice (e.g. advice to stop smoking) can be helpful to prevent LUs from returning. Previous work has shown that exercises focusing on improving the calf muscles (such as walking and heel raises) can improve the flow of blood out of the legs, reduce swelling and improve healing. There is reason to believe that these exercises as well as current treatments and lifestyle advice, are important to prevent a LU from coming back. However, more research is needed to show whether these ‘supportive’ treatments help.
The aim of this pilot study is to see if a home-based multicomponent programme (regular exercise, compression stockings and reinforcement of lifestyle advice) is acceptable to patients (e.g. do they take part in it and do they enjoy it).
Participants will be assessed using questionnaires on their general health and wellbeing, as well as their opinions regarding the acceptability of the programme, at the start of the programme and after completing the 3-month programme.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0129
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion