CompletedNot Applicable

In-shoe Pressures Associated With Footwear Fit Guidelines

United Kingdom26 participantsStarted 2022-12-15

Plain-language summary

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. 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Unconfirmed diabetes mellitus diagnosis * Inability to ambulate independently without walking aids * Presence of rheumatoid arthritis * 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 * Previous minor or major amputation * 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 * Blood pressure \>180/100 or \<90/50 * Unable to understand written and verbal English * PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicatin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

During the procedure difference in mean in-shoe PPP associated with each toe gap standard within standardised footwear @ regulated pace

Timeframe: During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%

During the procedure difference in the mean in-shoe PPP by ROI associated with each toe gap standard

Trial details

NCT IDNCT06025422

SponsorUniversity Hospitals, Leicester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials