Could smart insoles help monitor and improve diabetic foot health?

REAL PRETECTION - Preventing diabetic foot ulcers using real-time foot pressure monitoring and alert technologies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72155978

Enrollment

Registered

2023-04-17

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

In phase one of the project, 30 people with diabetes will use one of three smart insole technologies for 3 weeks (using it for as long as they can each day). Their experiences will be captured through

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of diabetes 2. Diabetic peripheral neuropathy (VPT =25 Volts and/or neuropathy disability score =6) 3. Capable of walking independently (30 steps, aids permitted) 4. Aged >18 years 5. Able to understand all of the study requirements

Exclusion criteria

Exclusion criteria: 1. Active/healed DFU within the last 3 months 2. Active Charcot neuroarthropathy 3. Absent pedal pulses 4. Limb/foot amputation (except toe amputations) 5. Cognitive impairment (Mini-Mental State Examination [Tombaugh & MacIntyre, 1992]) 6. Glomerular Filtration Rate (eGFR) <30 7. NHS prescription footwear unsuitable for smart device use (as assessed by a podiatrist)

Design outcomes

Primary

Measure	Time frame
Level of pressure offloading is measured using pressure metrics obtained from the devices used following high-pressure alerts across the 3-week study period	—

Secondary

Measure	Time frame
1. Device wear time is measured using time-in-use data metrics obtained from the devices used following the 3-week study period 2. Ease of use and user experience is measured using an adapted M-Health app usability questionnaire following each device intervention period 3. Technological capabilities are measured using a digital skills questionnaire following each device intervention period 4. Cognitive and emotional factors are measured using a patient interpretation of neuropathy questionnaire following each device intervention period 5. Adherence factors are measured using a Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire following each device intervention period 6. User skill is measured using the patient activation measure following each device intervention period	—

Measure

Time frame

1. Device wear time is measured using time-in-use data metrics obtained from the devices used following the 3-week study period 2. Ease of use and user experience is measured using an adapted M-Health app usability questionnaire following each device intervention period 3. Technological capabilities are measured using a digital skills questionnaire following each device intervention period 4. Cognitive and emotional factors are measured using a patient interpretation of neuropathy questionnaire following each device intervention period 5. Adherence factors are measured using a Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire following each device intervention period 6. User skill is measured using the patient activation measure following each device intervention period

—

Countries

England, United Kingdom

Contacts

Public ContactNeil Reeves

n.d.reeves1@lancaster.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026