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

This trial does not accept healthy volunteers

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 population

This study will enroll adult participants with diabetes who are at risk for diabetic foot complications and who are able to use a smartphone-based home monitoring system. Participants represent the intended user population of the Feetsee™ Foot Monitoring System. Participants will be recruited from diabetes, endocrinology, and podiatry clinics at UT Health San Antonio and affiliated University Health clinical sites under the supervision of the Principal Investigator.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device
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).

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Type 1 or Type 2 diabetes, recruited from outpatient clinics1 intervention

Trial outcomes

Primary outcomes

Usability of the Feetsee Foot Monitoring System

• 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

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diabetis JSC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: