Could smart insoles help monitor and improve diabetic foot health?

Not Applicable

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN72155978
• Lead Sponsor: Manchester Metropolitan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-17
• Last Update Posted: 3 October 2023
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 90

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified