Socksess - understanding the needs and preferences of people with diabetes to help co-design a smart sock and feedback system for prevention of diabetic foot ulcers
| ISRCTN | ISRCTN13991509 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13991509 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 323631 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 323631, CPMS 55647 |
- Submission date
- 17/04/2023
- Registration date
- 24/04/2023
- Last edited
- 19/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The 'Socksess' project aims to create new technology to help make people with diabetes aware of how much pressure they put on their feet and prevent ulcers. We will develop and test a new 'smart-sensing sock' that will 'reconnect people with their feet' and help prevent ulcers and amputations. Diabetes damages nerves in the feet, known as 'neuropathy', affecting 1 in every 2 people with diabetes. This can cause people to lose all sensation and feeling in their feet which means that people with diabetes and neuropathy put excessive pressure on their feet without knowing. With nerves that are damaged, people do not have any natural way of knowing how much pressure they put on their feet and can literally wear a hole in the bottom of their foot, known as a diabetic foot ulcer. Although they can start off as a small hole in the foot, a diabetic foot ulcer can become infected and someone may need to have part of their foot or leg removed (amputated) to stop the infection and save their life. In the UK, there are over 120 amputations every week because of a diabetic foot ulcer. In recent work using insoles named Orphyx, the study team showed proof-of-concept that providing pressure feedback to people using insoles can reduce diabetic foot ulcers. The study found that additional measurement of shear pressure (rubbing) would improve the prediction and prevention of diabetic foot ulcer formation. There are limitations in the ability of insoles to measure rubbing, so we are looking to adapt available technologies to develop a smart-sensing sock and feedback system that may provide a novel solution for the daily monitoring and prevention of diabetic foot ulcers. The present study will aim to do this through 'co-design' - working closely with people who have experience living with diabetes, their families and healthcare professionals, to develop the technology, make design choices and publicise the work. The study team will conduct interviews and focus groups with these people, to make sure that we understand their views, needs and preferences and can include these in the design of the smart-sensing sock. The study will also be supported by a panel of international experts in diabetic foot care and industry partners who will help guide long-term development, clinical evaluation and commercialisation.
Who can participate?
Adults with diabetes, their carers, or healthcare professionals who work with people with diabetes and diabetic foot ulcer.
What does the study involve?
After consenting to participate, people with diabetes and their carers will be interviewed about their needs and preferences with regard to the proposed design of the smart sock and feedback system. Healthcare professionals will discuss their needs and preferences in a focus group discussion.
What are the possible benefits and risks of participating?
There is no direct benefit to taking part in the interview. The process might help participants focus on the best ways to look after their own feet. Healthcare professionals may enjoy the opportunity to learn more about the technology and connect with other healthcare professionals. A certificate of participation is available for those who wish to use this for CPD/professional development. Participants will be compensated for their time. The only known ‘con’ of taking part is the time required to participate.
Where is the study run from?
The University of Southampton (UK)
When is the study starting and how long is it expected to run for?
January 2023 to February 2024
Who is funding the study?
Engineering and Physical Sciences Research Council (EPSCR) (UK)
Who is the main contact?
Jenny Corser, j.c.corser@soton.ac.uk (UK)
Contact information
Principal Investigator
Centre for Applications of Health Psychology
Academic Unit of Psychology, Shackleton Building (B44)
University of Southampton
Southampton
SO15 7BJ
United Kingdom
 ORCID ID |
0000-0001-5513-7571 |
|---|---|
| Phone | +44 (0)7926721965 |
| kjb1e08@soton.ac.uk |
Public
Centre for Applications of Health Psychology
Academic Unit of Psychology, Shackleton Building (B44)
University of Southampton
Southampton
SO15 7BJ
United Kingdom
| ORCID ID |
0000-0003-1491-1801 |
|---|---|
| Phone | +44 (0)2380 594215 |
| j.c.corser@soton.ac.uk |
Scientific
Centre for Applications of Health Psychology
Academic Unit of Psychology, Shackleton Building (B44)
University of Southampton
Southampton
SO15 7BJ
United Kingdom
| Phone | +44 (0)2380 594215 |
|---|---|
| j.c.corser@soton.ac.uk |
Study information
| Study design | Observational qualitative study design |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative |
| Study setting(s) | Community |
| Study type | Prevention |
| Scientific title | Socksess - Co-designing a digital health intervention: smart sensing socks for monitoring diabetic feet and preventing ulceration |
| Study acronym | SOCKSESS |
| Study hypothesis | In order to develop a technology that will be inclusive, accessible, useable, and promote effective engagement by people with and at risk of diabetic foot ulcer, their carers and healthcare providers, their needs and preferences need to be qualitatively explored and applied to the design and optimization of the technology. |
| Ethics approval(s) | Approved 16/03/2023, South Central - Hampshire B Research Ethics Committee (2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 (0)207 104 8088, (0)20 7104 8289, (0)20 7104 8289; hampshireb.rec@hra.nhs.uk), ref: 23/SC/0098 |
| Condition | Prevention of diabetic foot ulcer |
| Intervention | This study will be using a person-based approach (a combination of user-centred design and behavioural science) to codesign a smart-sensing sock and an associated feedback system to alert the user of high pressure and shear stress that may lead to developing a foot ulcer. The person-based approach enables a detailed understanding of target user needs and preferences in order to facilitate high-quality codesign that will lead to a digital intervention that is not just acceptable and feasible, but also appealing, persuasive, motivating and highly accessible, so that it is widely adopted and engaged with by users long-term. This involves conducting qualitative work with key stakeholders to explore their views of the new technology and what it needs to include to work for them personally. The study will run for 1 year. Qualitative interviews (approx 1hr) will be undertaken with people with diabetes and their carers, and a focus group (approx 90 mins) with healthcare professionals working in diabetes collecting information regarding the needs and preferences of these user groups to help co-design the smart sock and feedback system. |
| Intervention type | Other |
| Primary outcome measure | Qualitative data describing user needs and preferences of people with diabetes, their carers, and healthcare professionals. These data will be measured using individual bespoke qualitative interviews (for people with diabetes and their carers), and a focus group (for healthcare professionals) across the study period in order to iteratively guide the technology design process (occurring in a parallel study). |
| Secondary outcome measures | Brief demographic descriptives of the participant groups will be measured using a questionnaire conducted during the interview and prior to the focus group. |
| Overall study start date | 18/01/2023 |
| Overall study end date | 29/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 28 |
| Participant inclusion criteria | 1. Age over 18 years 2.1. Patients: Diagnosed with diabetes with/without a history of diabetic foot ulcer 2.2 Carers: Carer of a person with diabetes with/without diabetic foot ulcer 2.3 Clinicians: Healthcare professionals regularly managing people with diabetes and/or diabetic foot ulcers |
| Participant exclusion criteria | 1. Unable to understand and communicate in English 2. Severe mental illness that would interfere with their capacity to consent (e.g., dementia) 3. Diagnosed with terminal illness |
| Recruitment start date | 18/04/2023 |
| Recruitment end date | 25/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
The Oast
Hermitage Lane
Maidstone
ME16 9NT
United Kingdom
15 Marylebone Road
London
NW1 5JD
United Kingdom
Southall
UB2 4SD
United Kingdom
Sponsor information
University/education
Research and Innovation Services
University of Southampton
Room 2029, Building 28, Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)2390598580 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository at the University of Southampton • The type of data stored: we will collect personal contact information for the purposes of payment and arranging interviews etc, This will be kept for 3 years and then destroyed. The raw data will include interview and focus group transcripts and answers to the demographic questionnaire. This will be kept in the University of Southampton data storage facility for 10 years. There is a question on the consent forms (attached) to consent to the anonymised data being accessible to other researchers. For the interview participants, this is optional and so only interview transcripts of those who consent will be available. • The process for requesting access: via the University of Southampton https://www.southampton.ac.uk/legalservices/what-we-do/data-protection-and-foi.page • Timing for availability: data will be made available via the University of Southampton data repository after publication of our data analysis • Whether consent from participants was required and obtained: consent will be obtained • Comments on data anonymization: all transcripts will be anonymised (names and places removed) and any statements that could indicate the identity of the participant (e.g job description, timing of events) will be redacted. Personal information will be kept separately from the qualitative data. Pseudonyms and/or anonymous ID codes will be used to identify results in place of the participant names. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 13/03/2023 | 24/04/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 14/02/2025 | 19/03/2025 | Yes | No |
Additional files
Editorial Notes
19/03/2025: Publication reference and total final enrolment added.
28/11/2023: The recruitment end date was changed from 31/12/2023 to 25/10/2023.
24/04/2023: Trial's existence confirmed by NHS HRA.
