JMIR Publications

ABSTRACT

Background:

Diabetic foot ulcers (DFUs) are a leading cause of hospitalizations, amputations, and healthcare costs among individuals with diabetes, often due to delayed detection and treatment. Early identification of skin changes is critical for preventing ulcer progression, yet daily visual foot inspections are often limited by impaired mobility, visual deficits, and poor compliance. However, most existing foot-focused remote-patient-monitoring (RPM) approaches do not provide standardized, full-color visual documentation, which can reduce patient compliance and limit clinicians’ ability to interpret findings using familiar visual cues.

Objective:

This formative evaluation aimed to assess the usability, compliance, and preliminary clinical utility of an in-home full-color imaging scale for monitoring patients with diabetic foot ulcers to inform the design of larger prospective studies.

Methods:

We conducted a retrospective case series analyzing 7 months of pre-existing data from 21 adults (aged 43–86 years) with a prior history of DFUs who had previously been enrolled in an outpatient remote monitoring program. Participants were provided with an internet-connected in-home scale that captured high-resolution, full-color images of the plantar surface of the feet during daily use. Images were securely transmitted to a HIPAA-compliant web portal for clinician review. Usability was assessed through compliance to daily scanning, successful image transmission, and descriptive review of clinical workflows. Three representative cases were selected to illustrate real-world device use and clinical review processes.

Results:

Participants demonstrated high compliance and feasibility of home use, with reliable image acquisition and data transmission enabling consistent clinician review, as evidenced by device use on 82.5% of possible days and a median of 27 of 30 days. In three illustrative cases, remotely reviewed images prompted timely clinical attention for skin changes, including foreign body impaction, new ulceration, and early skin breakdown. These cases highlight how daily visual monitoring may support early clinical assessment and care plan adjustments. Participants reported high satisfaction with the device and minimal burden associated with daily use, with most participants rating the device as physically easy to use (median: 7.0; mean: 6.9 ± 0.5), expressing willingness to use it daily (median: 7.0; mean: 6.9 ± 0.3), and indicating trust in the system’s ability to detect foot-related issues (median: 7.0; mean: 6.9 ± 0.3) on a 7-point Likert scale (1=worst, 7=best).

Conclusions:

This retrospective case series demonstrates the preliminary usability and feasibility of an in-home, full-color imaging scale for daily remote visual monitoring of diabetic feet in a real-world outpatient setting. High compliance and successful integration into clinical workflows suggest that this approach may support early identification of foot-related concerns. Future prospective studies are warranted to evaluate the impact of this technology on clinical outcomes, including ulcer progression and healthcare utilization. Clinical Trial: N/A - this was a retrospective, observational analysis of previously collected remote patient monitoring data conducted for formative usability and feasibility evaluation. The study did not involve prospective assignment of interventions or randomization and therefore did not meet criteria for mandatory trial registration.