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

Part of paid clinical trials in Houston, Texas.

Sponsor
Texas Woman's University
Study ID
NCT05074849
Status
Not Yet Recruiting

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Conditions

  • Diabetes Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion — BEHAVIORAL
    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).

Study Details

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 Dates

Start date
Oct 20, 2026
Status verified
Apr 2025
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Smart insoles + Education
    Participants in this group will receive a 90-minute group session education on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch)
  • No Intervention: Smart Insoles
    Participants in this group will not receive a 90-minute group session education on foot self-care, but will receive foot care supplies, insoles and smart watch
  • No Intervention: Usual Care
    Participants will not receive foot self-care education or the use of insoles and smart watch.

Primary Outcome Measure

A Change in Adherence to prescribed footwear is being assessed [ Time Frame: 2 months, 4 months and 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030-
Texas Woman's UniversityHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Baylor College of Medicine· Houston, TXTexas Woman's University· Houston, TX

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