Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Diabetis JSC
Study ID
NCT07666087
Status
Not Yet Recruiting

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Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device — DEVICE
    : after initial training, participants set up and use the Feetsee foot-monitoring system in their own homes, following the US IFU and in-app instructions. Data will be collected via paper/electronic CRFs, patient questionnaires, and Feetsee device/app usage logs (exported to REDCap and secure sponsor databases).

Study Details

Single-center, prospective, minimal-risk, non-experimental usability study assessing the setup and use of the FDA-registered (Class I medical device; 510(k)-exempt) Feetsee™ home foot-monitoring system by adults with diabetes in their home environment over 8 weeks. This study in non clinical, observational pilot usability study conducted under FDA Human Factors and Usability Engineering guidance (2016).

Key Dates

Start date
Jul 10, 2026
Status verified
Jun 2026
Primary completion
May 27, 2027
Completion
Jul 10, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Type 1 or Type 2 diabetes, recruited from outpatient clinics
    Approximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio

Primary Outcome Measure

Usability of the Feetsee Foot Monitoring System [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health San AntonioSan AntonioTexas78229
Nick Lucio
[email protected]
210-567-5142
Lawrence A. Lavery, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UT Health San Antonio· San Antonio, TX

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