Assessing footwear fit for people with diabetes and neuropathy
Evaluation of Footwear Fit Guidelines Under Pressure in At-Risk Feet
This study is testing if different shoe fitting guidelines can help people with diabetes and nerve damage reduce pressure on their feet to lower the risk of foot ulcers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06025422 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of different footwear fit guidelines on in-shoe pressures in individuals with diabetes and neuropathy. A total of 60 participants will be recruited, and their foot measurements will be taken to create custom-fit shoes. Participants will walk at a consistent pace while wearing standardized footwear, and in-shoe pressures will be measured using insoles. The study will compare the pressure differences between two footwear fit standards to determine which is more effective in minimizing risks associated with foot ulcers.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-80 with a confirmed diagnosis of diabetes and neuropathy who can walk unaided.
Not a fit: Patients with active ulcers, recent healing ulcers, or other significant foot conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved footwear recommendations that reduce the risk of foot ulcers in diabetic patients.
How similar studies have performed: While there is limited research specifically on footwear fit guidelines for diabetic patients, similar studies have shown the importance of proper footwear in preventing foot complications.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leicester, Leicestershire
- Leicester Diabetes Centre — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Petra J Jones — University Hospitals, Leicester
- Study coordinator: Petra J Jones
- Email: pj100@leicester.ac.uk
- Phone: 0116 258 4974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.