Benefits of Insoles With Real-Time Alert and Foot Self-Care Education

Launched by TEXAS WOMAN'S UNIVERSITY · Sep 29, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with diabetes take better care of their feet and prevent serious foot problems, like ulcers. The researchers are testing special insoles that work with a smartwatch to give real-time alerts and reminders about foot care. Along with this technology, participants will receive education on how to properly care for their feet while wearing their prescribed diabetic footwear. The goal is to encourage patients to use their footwear more consistently and reduce the risk of foot ulcers, which can be a common complication for those living with diabetes.

To be eligible for this trial, participants should be at least 18 years old, have a diagnosis of diabetes, and currently use prescribed footwear for their condition. They should also be able to attend follow-up appointments, even if that means traveling a bit. However, individuals with certain serious foot issues, recent heart or lung problems, infections, or significant cognitive difficulties will not be included in the study. If you join the trial, you can expect to use the new insoles and smartwatch, attend educational sessions, and have regular check-ins to monitor your progress and foot health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men or women 18 years old or older,
• • Diagnosis of Diabetes Mellitus,
• • Ambulatory, Uses prescribed diabetes footwear.
• • Those willing and able to attend follow up visits such as long distance (i.e. greater than 30 miles to recruitment sites).
• • Those able to read or follow directions.
• Exclusion Criteria:
• • Active Charcot Arthropathy or major foot deformity,
• • Cardiopulmonary disease (e.g. recent MI, Stroke),
• • Gangrene, active infection. Montreal Cognitive Assessment (MOCA\<20).
• • Wide spread malignancy or systemically immunocompromising disease.