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NCT Number: NCT06200532

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. 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Research Centre

Leicester, Leicestershire, LE5 4PW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

FOOTSAK (FOOTwear self-assessment kit)

Other

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)

Primary outcomes

  1. Accuracy

    Time frame: Visit 1 on day 1

    Accuracy: average (mean) variation of study participants' foot and footwear measurements from a trained researcher's measurements and standard error of measurements.

  2. Reliability

    Time frame: Visit 1 on day 1

    Intrarater reliability (Intraclass Correlation Coefficient) based on four measurements of the feet and footwear by study participants

  3. Ease of use scores

    Time frame: Visit 1 on day 1

    Mean ease of use visual analogue scores (i) both overall and for each section of instructional material; (ii) for each study video / demonstration and overall; and (iii) both overall and for each measuring tools included within the FOOTSAK

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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