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Not yet recruiting NCT07666087

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

— Observational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

Participants will be recruited from outpatient diabetes and podiatry clinics at UT Health San Antonio, an academic medical center. The study itself is conducted as a home-use usability study: 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).

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).

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • Males and females aged 18 years or older
  • Clinical diagnosis of Type 1 or Type 2 diabetes
  • At least one palpable foot pulse per feet
  • Possess basic ability to use a smartphone or tablet
  • Have no prior experience with the Feetsee™ system
  • Be willing and able to provide informed consent

Exclusion criteria

  • Active foot ulceration at enrollment
  • Active Charcot neuro-osteoarthropathy
  • Severe vascular disease (complete absence of foot pulses)
  • Amputation of more than three toes
  • Active malignancy or immunosuppressive condition
  • Cognitive or physical impairments preventing proper device usage
  • Concurrent participation in another investigational study with contraindicated procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UT Health San Antonio — San Antonio

Identifiers

NCT: NCT07666087 · FS-US_02-PR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗