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NOT YET RECRUITING
NCT05074849
NA

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

Sponsor: Texas Woman's University

View on ClinicalTrials.gov

Summary

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.

Official title: Benefits of Insoles With Real-Time Alert and Foot Self-Care Education in Improving Adherence for Prescribed Footwear in Patients With Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-10-20

Completion Date

2026-12-30

Last Updated

2025-04-16

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion

A 90-minute group session to educate patients on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch). Follow-up Care: A biweekly 30-minute one-on-one follow-up phone discussion (i.e., daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch, addressing feedback and questions regarding the intervention and prevention of foot-related complications).

Locations (2)

Baylor College of Medicine

Houston, Texas, United States

Texas Woman's University

Houston, Texas, United States