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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Petra
Jones
footwearfit@uhl-tr.nhs.uk
Rachel
Berrington
rachel.berrington@uhl-tr.nhs.uk
Diabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed their effectiveness in minimising in-shoe pressures.
We will carry out a pilot study in 60 people with diabetes and loss of sensation in their feet (neuropathy). In this study, we will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside their shoes will measure in-shoe pressures. They will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear between shoes whose fit conforms to Standard 1 guidance compared with those whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm.
We will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards. Footwear fit will be determined by measuring the dimensions of participants’ feet and that of their footwear and comparing the two.
We will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants’ habitual footwear during walking at paced and self-selected speeds.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
- Unconfirmed diabetes mellitus diagnosis [from medical records] - Inability to ambulate independently without walking aids [visual inspection] - Presence of rheumatoid arthritis (Given swelling around joints may affect fit or potential impact of arthritic pain on plantar pressure distribution) [visual inspection /from medical records] - Active ulcer (i.e. having an active ulcer at the time of recruitment) or an ulcer which has had less than six months to fully heal, or a history of Charcot in foot/joints [visual inspection/from medical records] - Previous minor or major amputation [visual inspection/from medical records] - Neurological disorders other than diabetes-related neuropathy potentially affecting gait, balance or posture [visual inspection/from medical records] - Evidence of significant peripheral vascular disease e.g. (i) attendance at a specialist vascular clinic; (ii) documentation of occlusive arterial disease or intervention; (iii) at least one pulse should be palpable on the affected foot with exclusion where neither pulse is palpable [from medical records / palpable pulse] - Blood pressure > 180/100 or < 90/50 [from blood pressure test] - Unable to understand written and verbal English [assessed during consenting process] - PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking [from PAR-Q completion]
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST and funded by THE BRITISH DIABETIC ASSOCIATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 53932
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