The use of softcast heel protectors for the prevention of heel ulcers
Research type
Research Study
Full title
The use of softcast heel protectors for the prevention of heel pressure ulcers in people with and without diabetes: A randomised controlled pilot study.
IRAS ID
159127
Contact name
Alan Simpson
Contact email
Sponsor organisation
Leeds Community Healthcare Trust
Duration of Study in the UK
0 years, 7 months, 14 days
Research summary
Pressure ulcers are caused when an area of skin and the tissues below are damaged as a result of being placed under pressure. Typically they occur in people confined to bed or a chair by an illness. They are sometimes referred to as “bedsores” or “pressure sores”. Heels are a common site of occurrence.
The total cost of treating all pressure ulcers in the UK has been estimated at between 1.4 to 2.1 billion pounds, approximately 4% of the NHS budget.
Softcast heel protectors are custom-made semi-flexible devices made by Podiatrists and Nurses to improve healing in pressure ulcers on heels. No research has been done to determine if they can be used to prevent heel pressure ulcers. We will undertake a pilot randomized intervention trial to investigate this.This study will be based on NICE Clinical guideline 179 on Prevention and management of pressure ulcers (April 2014), and the Cochrane review on Pressure relieving devices for preventing heel pressure ulcers (March 2013).
The study will have a minimum total size of 60 participants (30 in two arms) recruited from District Nursing records in Leeds Community Healthcare. All participants will be at risk of heel pressure ulcers as defined by NICE guideline 179.
On enrolment (and provision of consent) participants will be randomly allocated into either the intervention arm (use of a softcast heel protector) or the non-intervention arm (standard clinical care). Participants will be followed up for 6 months and assessed regularly during this time to monitor if a category two ulcer develops (the primary outcome).
This study will estimate the association between the risk of developing a heel pressure ulcers and the use of softcasts in people at risk of developing them.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1187
Date of REC Opinion
17 Oct 2014
REC opinion
Unfavourable Opinion