Unloading shoes for intermittent claudication
Research type
Research Study
Full title
Randomised crossover study with nested qualitative component investigating the clinical efficacy and acceptability of unloading shoes in patients with intermittent claudication due to peripheral arterial disease
IRAS ID
167755
Contact name
Garry Tew
Contact email
Sponsor organisation
Chelsea and Westminster NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of leg artery disease. Patients with IC struggle to walk, which in turn lowers their quality of life.
The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC.
A member of the research team (Dr Stephen Hutchins) has developed a shoe that reduces the work done by the lower-leg muscles during walking. When wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes.
Thirty-six people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0107
Date of REC Opinion
6 May 2015
REC opinion
Further Information Favourable Opinion