Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200532
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-12-19
Brief Title:
FOOTSAK Footwear Self-Assessment Kit
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
Footwear Self-Assessment Kit for People With Diabetes at Risk of Ulceration - A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 videosshort 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 083 for footwear length and 072 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 70 100 using Visual Analogue Score with free text comments Any measuring tool failing to obtain a score of 70 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI
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 videosshort 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 083 for footwear length and 072 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 70 100 using Visual Analogue Score with free text comments Any measuring tool failing to obtain a score of 70 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None