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NCT05074849 · ClinicalTrials.gov registry record · NA
Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
A NA study, sponsored by Texas Woman's University.
- Not yet
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT05074849: Clinical Trial NA study, sponsored by Texas Woman's University.
NCT05074849 is a NA study that has not yet begun recruiting, run by Texas Woman's University. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05074849, a NA study, has not yet begun recruiting, sponsored by Texas Woman's University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2026-10-20 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What is known before NCT05074849 opens enrollment
NCT05074849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion is the first listed.
NCT05074849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05074849 about?
NCT05074849 is a clinical study titled "Benefits of Insoles With Real-Time Alert and Foot Self-Care Education". 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 ...
What is the current status of trial NCT05074849?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2026-10-20. Estimated completion is 2026-12-30.
What interventions are being tested in trial NCT05074849?
The interventions under investigation include: A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion (BEHAVIORAL).
Who is sponsoring clinical trial NCT05074849?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05074849's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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