DiabetesNCT07666087
Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
An observational study of Diabetes, run by Diabetis JSC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 10 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rytis Zajančkauskas, MD contact
United States1 site
UT Health San Antonio
San Antonio, Texas, 78229
Nick Lucio, 210-567-5142, luciond@uthscsa.edu
Lawrence A. Lavery, MD
About this study
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).
Read the 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).
- Conditions
- Diabetes
- Being tested
- Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device
- Keywords
- Foot monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring DeviceDevice
: 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).
| Study group | Role | What they receive |
|---|---|---|
| Type 1 or Type 2 diabetes, recruited from outpatient clinics | Approximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio Receives: Device: Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jul 2026 (estimated)
- Primary completion27 May 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetis JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence A. Lavery, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666087
- Sponsor's protocol ID
- FS-US_02-PR
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
- ClinicalTrials.gov ID
- NCT07666087
- Acronym / sponsor ID
- FS-US_02-PR
- Conditions
- Diabetes
- Keywords
- Foot monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Diabetis JSCIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 or Type 2 diabetes, recruited from outpatient clinics | – | Device: Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring DeviceApproximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot 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). | Device | Type 1 or Type 2 diabetes, recruited from outpatient clinics |
Primary outcome
Usability of the Feetsee Foot Monitoring System
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rytis Zajančkauskas, MD contact
Lawrence A. Lavery, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Diabetis JSC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Grinberg, PhD (+31615636666, lenagrin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Feetsee Foot Monitoring System (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.