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This study aims to design, develop, and evaluate a smart insole to predict the formation of diabetic foot ulcers (DFUs) in diabetic participants at risk of developing them. The study will be conducted in two phases, using mixed-method research and engaging both diabetic participants and NHS clinicians. In Phase 1, the user-centred design of the smart insole will be developed through focus groups and online questionnaires, and a preliminary safety evaluation of the insole will be conducted with healthy team members. In Phase 2, the insole will be tested, validated, and data will be collected through baseline visits, lab studies, and insole data collection with shape-changed (pressure off-loading) insoles. The study will be conducted by researchers from the University of Manchester and the University of Exeter. It will include 10 people with diabetes and 10 healthy controls in Phase 2.
Full description
The tasks in this phase will be conducted by researchers from the University of Manchester and the University of Exeter. All tasks will be held at the University of Exeter.
Recruited participants will attend three sessions (tasks) on three non-consecutive days in the span of three months.
Participants will be identified either through participant identifying centres (e.g., Manchester diabetes clinic) or through direct contact from ad response. From these identified patients, lists will be screened by either general practitioners (for National Health Service (NHS) sites) or the University of Manchester and University o Exeter researchers (for direct contact) according to eligibility criteria. Eligible participants will be written to and invited to return a reply slip detailing whether they are interested in taking part. The return slips will contain all necessary details of the study, including participant information sheets. These must be given to eligible participants at least 48 hours before any planned interview sessions.
Eligible participants that return reply slips, or email the research team to say they are interested, will be contacted by phone by a researcher to clarify any questions they may have. The researcher will then notify the participant of the schedule for the sessions. On the arranged date, before the sessions, the participant will complete the consent process.
n = 20 (10 diabetic participants, 10 healthy similar controls)
Task 2.1 Baseline Visit: Eligibility confirmation and health screening session
Consented participants will be asked to attend an eligibility confirmation, health evaluation and foot measurements session.
This includes:
Data Collection Method:
Gait and core kinematics evaluation data will be collected in the form of electronic signals (from Intreial Measurement Unit (IMU) sensors) and videos (motion capture cameras)
Data collected during the baseline visit will be both qualitative and quantitative.
Qualitative data:
i. Signed participant forms - (i) Decisional capacity evaluation, (ii) consent, (iii) inclusion/exclusion ii. Demographic data - age, sex, weight, iii. Physical Activity Readiness Questionnaire (PAR-Q) iv. Researcher notes v. Monofilament foot test for neuropathy - noted as yes/no for neuropathy.
Quantitative data:
a. Quantitative data collected within this task are: i. Gait and core kinematics evaluation: using Inertial Measurement Unit (IMU) sensors (physiobiometric) and motion capture cameras and Azure Kinect (data = video files collected and reviewed in the university-managed computer). This will be analysed using Statistical Package for the Social Sciences (SPSS) v.28 or onwards ii. Foot pressure readings (standing) will be collected via HR-Mat in the form of electronic signals that is collected via the HR-Mat Tekscan Research app in a university-managed laptop.
Task 2.2 Pilot laboratory - Insole data collection • The first study (Task 2.2) is a pilot evaluation in the lab to collect insole data for a series of activities. The activities are the same between the diabetic and control groups:
Participants will be asked to wear the smart insole while sitting (10 minutes), standing (5 minutes), and walking on a treadmill at a self-selected normal pace (15 minutes).
Participants will be asked to repeat the procedure after a 20 minutes rest.
After repeating the procedure, participants will rest for up to 15 minutes, after which participants will be asked to do a final short 2-5 minute walk on the ground.
Participants will be asked for feedback on the insole and their experience with the study.
Data Collection Method:
Participant health (heart rate, blood pressure and blood glucose)
Participant satisfaction, experience and feedback on the insole/study will be collected through a questionnaire that can either be answered via an electronic questionnaire or a physical copy.
Task 2.3 Lab study- insole data collection with shape-changed (pressure shape changed) insole
The second study (Task 2.3) pilot evaluation in the lab to collect insole data for a series of activities with a bespoke shape-changed insole to offload the pressures of the foot. The procedures (study methods and data collection) will be as follows:
Participants' health will be monitored throughout the study- heart rate, blood pressure, and blood glucose
Enrollment
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Inclusion and exclusion criteria
Diabetic Group
Inclusion Criteria:
Confirmed diagnosis of diabetes
1)At the risk of developing a DFU 2) Able to understand and communicate to safely participate [Brief Assessment of Capacity 3) to have a score at least 6/8 (UBACC)]Capacity to participate 4) capability to walk for 10 mins without rest 5) Be able to walk for 30 minutes with no pain, no walking aid, and take breaks if required.
Exclusion Criteria:
Healthy participants
Inclusion Criteria:
Exclusion Criteria:
20 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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