FOOTSAK
Research type
Research Study
Full title
Footwear Self-Assessment Kit for people with diabetes at risk of ulceration – A feasibility study
IRAS ID
286568
Contact name
Ehtasham Ahmad
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
People with diabetes are vulnerable to patches of broken skin called foot ulcers which are difficult to heal. One in five ulcers are caused by incorrectly fitting footwear.
FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width.
We will recruit ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation to use the FOOTSAK (Fig.1). Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), we will also recruit ten ‘Footwear buddies’ - people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate).
Both participants are asked to watch instructional videos and read large text instructions (see FIG.2). Footwear buddies are asked to repeatedly measure the feet of people with diabetes. People with diabetes are asked to repeatedly measure their footwear then assess whether they are correctly fitting. The feet and footwear of participants with diabetes are then measured by a trained researcher to determine accuracy.
The feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF).
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/LO/1007
Date of REC Opinion
1 Feb 2024
REC opinion
Further Information Favourable Opinion