In-shoe Pressures Associated with Footwear Fit Guidelines

Launched by UNIVERSITY HOSPITALS, LEICESTER · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well different types of shoe fits can help people with diabetes avoid foot ulcers, which can be caused by improper footwear. The researchers want to find out if there is a difference in the pressure inside shoes when people walk, depending on how much space is left for their toes. They will have 60 participants, who have diabetes and nerve damage in their feet, walk in specially designed shoes while their foot pressures are measured. The study will compare three different toe gap sizes to see which one might be best for reducing pressure and preventing injuries.

To be eligible for this study, participants should be between 18 and 80 years old, have a confirmed diagnosis of diabetes and nerve damage, and be able to walk independently for at least 200 steps. Participants will wear the same type of shoes and walk to a steady rhythm while their foot pressure is recorded. The study aims to learn more about how shoe fit can affect foot health in people with diabetes, and it will also look at how participants' usual shoes compare in terms of comfort and pressure while walking.

Gender

ALL

Eligibility criteria

• 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 indicating unsuitability for mild physical exercise involved in walking