Diabetes MellitusNCT06200532
FOOTSAK (Footwear Self-Assessment Kit)
A study testing FOOTSAK (FOOTwear self-assessment kit) in people with Diabetes Mellitus, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FOOTSAK (FOOTwear self-assessment kit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Research Centre
Leicester, Leicestershire, LE5 4PW
About this study
Official title: Footwear Self-Assessment Kit for People With Diabetes at Risk of Ulceration - A Feasibility Study
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).
Read more
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.
- Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher.
- 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).
- 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
- Being tested
- FOOTSAK (FOOTwear self-assessment kit)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Single cohort of people using home footwear self-assessment kit | Experimental | 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).
We will recruit ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), we will also recruit ten 'Footwear buddies' - 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). Receives: Other: FOOTSAK (FOOTwear self-assessment kit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy: average (mean) variation of study participants' foot and footwear measurements from a trained researcher's measurements and standard error of measurements.
Measured: Visit 1 on day 1
Reliability
Intrarater reliability (Intraclass Correlation Coefficient) based on four measurements of the feet and footwear by study participants
Measured: Visit 1 on day 1
Ease of use scores
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
Measured: Visit 1 on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start21 Mar 2024
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200532
- Sponsor's protocol ID
- 0947
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones PJ, Bullock J, Weaving L, Davies MJ, Razieh C, Ahmad E. Effectiveness of diabetes footwear fit assessment by people with diabetes and their family or partners: A reliability study. Diabet Med. 2025 Aug;42(8):e70065. doi: 10.1111/dme.70065. Epub 2025 Jun 15.
PubMed 40518605
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Footwear Self-Assessment Kit for People With Diabetes at Risk of Ulceration - A Feasibility Study
- ClinicalTrials.gov ID
- NCT06200532
- Acronym / sponsor ID
- 0947
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher.
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort of people using home footwear self-assessment kit | Experimental | 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. 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). We will recruit ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), we will also recruit ten 'Footwear buddies' - 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Single cohort of people using home footwear self-assessment kit |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 40518605Jones PJ, Bullock J, Weaving L, Davies MJ, Razieh C, Ahmad E. Effectiveness of diabetes footwear fit assessment by people with diabetes and their family or partners: A reliability study. Diabet Med. 2025 Aug;42(8):e70065. doi: 10.1111/dme.70065. Epub 2025 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOOTSAK (FOOTwear self-assessment kit) in people with Diabetes Mellitus, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Visit 1 on day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.