Diabetes
Conditions
Keywords
Foot monitoring
Brief 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).
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
DEVICEPilot 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
Diabetis JSC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of the Feetsee Foot Monitoring System | 8 weeks | • To evaluate the usability of the Feetsee Foot Monitoring System by both patients and healthcare providers when they use only the provided labeling, Quick Start Guide, Instructions for Use (IFU), and in-app instructions |
Countries
United States
Contacts
CONTACTHelena Grinberg, PhD
CONTACTRytis Zajančkauskas, MD
PRINCIPAL_INVESTIGATORLawrence A. Lavery, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed