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Insoles with Real-Time Alert and Foot Self-Care Education for Diabetes

This study is looking at new ways to help people with diabetes avoid foot ulcers, which are serious foot sores. It's testing if special insoles that give real-time alerts, combined with education on how to care for your feet, can help you stick to wearing your prescribed diabetic footwear. Researchers believe this could reduce foot ulcers. To join, you must be 18 or older, have diabetes, be able to walk, and already use prescribed diabetic footwear. The study will measure how well people follow their footwear recommendations over 6 months. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 72 participants. It is not specified if it is randomized or blinded.
What's involved
You would attend a 90-minute group session for foot self-care education. This is followed by bi-weekly 30-minute one-on-one phone discussions.
Compensation
Not stated in the trial record.
Follow-up
Your adherence to prescribed footwear will be measured at 2 months, 4 months, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05074849

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

Not Yet Recruiting
NAAges 18+InterventionalPrevention
Texas Woman's University
~72 participants
Updated 2025-04-16 on ClinicalTrials.gov
What's tested:A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A Change in Adherence to prescribed footwear is being assessed
Measured over 2 months, 4 months and 6 months

Conditions

Diabetes Complications

Explore related trials

Diabetes Mellitus

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Ngozi Mbue · PRINCIPAL_INVESTIGATOR · Texas Woman's University

Who to contact

Ngozi Mbue, PhD
[email protected]
7137942892
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • A Change in Adherence to prescribed footwear is being assessed2 months, 4 months and 6 months

    Daily adherence will be track by Sensor Data and Self-Report Questionnaire. The real-time alert component of the smart insoles will be measured by the tagging of patients' diabetes shoes by Orthimeter (Germany). The system has 1-year battery life and enables continuous measuring adherence to footwear by measuring temperature. Participants will be required to record number of days adhered to footwear or alerts.