Status:
COMPLETED
FOOTSAK (Footwear Self-Assessment Kit)
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear ...
Eligibility Criteria
Inclusion
- People with type 1 or type 2 diabetes; with or without neuropathy; with or without a history of ulceration who have not had a minor or major amputation;
- 'Footwear buddies' who consist of people with or without diabetes who are willing to measure the feet of participating people with diabetes - for example, a spouse, partner, carer, friend, neighbour, or housemate.
- Inclusion criteria for participant type (1)
- people who self-report as having type 1 or type 2 diabetes;
- aged 18 years or over
- without minor or major amputation
- Without significant foot deformity
- Able to read and understand English
- Willingness and capacity to participate in the study and to sign the informed consent form
- Inclusion criteria for participant type (2)
- Aged 18 or over
- Willing to act as a 'footwear buddy' for a person with diabetes
- Able to read and understand English
- with a willingness and capacity to participate in the study and to sign the informed consent form
- Exclusion criteria for participant type (1)
- Does not self-report as having diabetes (either type 1 or 2)
- Not aged 18 or over
- Has minor or major amputation
- Has significant foot deformity
- Unable to read and understand English
- Unwilling or lacking capacity to participate
- Exclusion criteria for participant type (2)
- Not aged 18 or over
- Unwilling to act as a 'footwear buddy' for a person with diabetes
- Unable to read and understand English
- Unwilling or lacking capacity to participate in the study
Exclusion
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06200532
Start Date
March 21 2024
End Date
January 7 2025
Last Update
April 3 2025
Active Locations (1)
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1
Diabetes Research Centre
Leicester, Leicestershire, United Kingdom, LE5 4PW