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

NCT07666087 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-06-24

No results posted yet for this study

Summary

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).

Conditions

Interventions

DEVICE

Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring 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).

Sponsors & Collaborators

  • Diabetis JSC

    lead INDUSTRY

Principal Investigators

  • Lawrence A. Lavery, MD · The University of Texas Health Science Center at San Antonio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2027-05-27
Completion
2027-07-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666087 on ClinicalTrials.gov