Sign in
CompletedNo phase

In-shoe Pressures Associated With Footwear Fit Guidelines

Key facts

Who runs it
University Hospitals, Leicester
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
26 people enrolled
Started
15 Dec 2022
Ended
30 Jun 2025
Type of study
Observational
Record updated
5 January 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Men and women aged 18-80 years
  • Confirmed diagnosis of diabetes mellitus type 1 or type 2
  • Confirmed diagnosis of neuropathy
  • Able to walk unaided for a minimum of 200 steps with capacity to attend the research site
  • PAR-Q physical activity questionnaire does not indicate any possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking
  • Willingness and capacity to participate in the study and to sign the informed consent form

Who cannot take part

  • Previous minor or major amputation
  • Unconfirmed diabetes mellitus diagnosis
  • Active ulcer (i.e. having an active ulcer at the time of recruitment)
  • Recently healed ulcer (an ulcer which has had less than six months to fully heal)
  • History of Charcot in foot/joints
  • Neurological disorders other than diabetes-related neuropathy potentially affecting gait, balance or posture
  • 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
  • PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking
  • Inability to ambulate independently without walking aids
  • Presence of rheumatoid arthritis
  • Blood pressure >180/100 or <90/50
  • Unable to understand written and verbal English

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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 the recommendations' effectiveness in minimising in-shoe pressures.

Read full original descriptionShow less

The investigators will carry out a pilot study in 60 people with diabetes and loss of foot sensation (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside participants' shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear whose fit conforms to Standard 1 guidance compared with footwear 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.

The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of participants' footwear and comparing the two.

The investigators 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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Footwear Fit Guidelines Under Pressure in At-Risk Feet
Record updated
5 January 2026