Not Yet RecruitingNot Applicable

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

United States72 participantsStarted 2026-10-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

A Change in Adherence to prescribed footwear is being assessed

Timeframe: 2 months, 4 months and 6 months

Trial details

NCT IDNCT05074849

SponsorTexas Woman's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Ngozi Mbue, PhD

7137942892 nmbue@twu.edu

View on ClinicalTrials.gov More Diabetes Complications trials