NCT06200532

FOOTSAK (Footwear Self-Assessment Kit)

Footwear Self-Assessment Kit for People With Diabetes at Risk of Ulceration - A Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 has adequate length and width. This feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF). Ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation will be recruited to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), ten 'Footwear buddies' - will also be recruited. These are people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate). Both participants are asked to watch instructional videos/short demonstrations and read large text instructions. Footwear buddies are asked to repeatedly measure the feet of people with diabetes. People with diabetes are asked to repeatedly measure their footwear then assess whether they are correctly fitting. The feet and footwear of participants with diabetes are then measured by a trained researcher to determine accuracy. 1. Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher. 2. Determine whether repeated footwear and foot measurements made by participants are reliable: Intraclass Correlation Coefficient ≥0.83 for footwear length and ≥0.72 for footwear width (assuming a 15% decrease in reliability when compared to a trained researchers' scores). 3. Determine whether FOOTSAK measuring tools and instructional materials ease of use ≥7.0 /10.0 using Visual Analogue Score with free text comments. Any measuring tool failing to obtain a score of 7.0 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	FOOTSAK (FOOTwear self-assessment kit)	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 has adequate length and width. It includes measuring tools (an internal footwear length gauge, scale dividers for measuring internal footwear width, a slide rule for measuring foot length and width, a ruler and magnifying glass for reading off measurements) and instructional materials (booklet instructions and video materials)

Timeline

• Start date: 2024-03-21
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2024-01-11
• Last updated: 2025-04-03

Locations

1 site across 1 country: United Kingdom