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

Starting soon

Conditions studied: Diabetes

In brief

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 facts

Study ID

NCT07666087

Run by

Diabetis JSC

People needed

20

Starts

2026-07-10

Expected to finish

2027-07-10

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT Health San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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