MedTrace Logo

Happier Feet- A Smart Insole for Diabetic Foot Ulceration Prevention

NCT05865353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-07-24

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Loughborough University

    collaborator OTHER

  • University of Southampton

    collaborator OTHER

  • University of Strathclyde

    collaborator OTHER

  • University of Exeter

    lead OTHER

Principal Investigators

  • Helen Dawes, PhD · Professor of Clinical Rehabilitations

  • Andrew Weightman, PhD · Professor of Medical Mechatronics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-08-30
Completion
2023-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865353 on ClinicalTrials.gov