Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes (NCT07666087) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
United States20 participantsStarted 2026-07-10
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.