Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Helena Grinberg, PhD; Phone Number: +31615636666; Email: lenagrin@gmail.com
• Study Contact Backup: Name: Rytis Zajančkauskas, MD; Phone Number: rytis@diabetis.lt

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
      • Contact: Nick Lucio; Phone Number: 210-567-5142; Email: luciond@uthscsa.edu
      • Principal Investigator: Lawrence A. Lavery, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Diabetis JSC
• Investigators: Principal Investigator: Lawrence A. Lavery, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): July 10, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Foot monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: FS-US_02-PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No