Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDiabetis JSC
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Active foot ulceration at enrollment
Active Charcot neuro-osteoarthropathy
Severe vascular disease (complete absence of foot pulses)
Amputation of more than three toes
Trial design
Treatments tested in this trial
- Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov