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

Starting soon · Not applicable

Conditions studied: Diabetes Complications

In brief

Novel approaches to promote adherence to diabetic footwear and prevent high incidence of diabetes foot ulcers are urgently needed. Investigators propose to translate an innovative and practical technology to supplement clinical and risk evaluation for patients with diabetes through wearable insoles and smart watch, along with foot self-care education, to improve adherence to prescribed footwear and reduce incidence of foot ulcers in those with diabetes and at risk for foot ulcers.

Key facts

Study ID

NCT05074849

Run by

Texas Woman's University

People needed

72

Starts

2026-10-20

Expected to finish

2026-12-30

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Texas Woman's University — Houston, Texas, United States

Full record on ClinicalTrials.gov

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