Status:
COMPLETED
In-shoe Pressures Associated With Footwear Fit Guidelines
Lead Sponsor:
University Hospitals, Leicester
Collaborating Sponsors:
University of Salford
Conditions:
Diabetic Foot Ulcer
Diabetic Neuropathies
Eligibility:
All Genders
18-80 years
Brief 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 ins...
Detailed Description
The investigators will recruit 60 participants with diabetes, neuropathy and a history of ulceration. The investigators will set a minimum target recruitment number for each sex (25 minimum for each)....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06025422
Start Date
December 15 2022
End Date
June 30 2025
Last Update
January 5 2026
Active Locations (1)
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1
Leicester Diabetes Centre
Leicester, Leicestershire, United Kingdom, LE5 4PW