Usability and Feasibility of an In-Home Full-Color Imaging Scale for Remote Monitoring of High-Risk Patients With a History of Diabetic Foot Ulcers: Retrospective Observational Formative Evaluation.

BACKGROUND

Diabetic foot ulcers (DFUs) are a leading cause of hospitalizations, amputations, and health care 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 self-inspections are often limited by impaired mobility, visual deficits, and poor compliance. Although some foot-focused remote patient monitoring technologies are in use, most of these approaches do not provide standardized, full-color visual documentation, which can affect clinicians' ability to interpret findings using familiar visual cues.

OBJECTIVE

This formative evaluation aimed to assess the usability, compliance, and feasibility of an in-home full-color imaging scale for the remote monitoring of patients with DFUs to inform the design of larger prospective studies.

METHODS

We conducted a retrospective formative feasibility evaluation analyzing 7 months of preexisting data from adults with a history of DFUs who had enrolled in an outpatient remote monitoring program. During this program, participants were provided with an internet-connected in-home scale that captured high-resolution, full-color scans of the plantar surface of the feet during daily use. Scans were securely transmitted to a HIPAA (Health Insurance Portability and Accountability Act)-compliant web portal for podiatrist review. Usability was assessed through compliance with daily scanning, patient and physician surveys, and descriptive review of clinical workflows.

RESULTS

A total of 21 participants aged 43 to 86 years (median 65, IQR 59-74; mean 65.3, SD 10.6 years) were retrospectively analyzed. Participants demonstrated high compliance and feasibility of home use, with device use on 82.5% (3638/4410) of possible days, a median use of 27 days (IQR 21-30) per 30-day period, and a mean use of 23 (SD 6.4) days per 30-day period. Participants reported high satisfaction and minimal burden associated with daily use, with most rating the device as physically easy to use (median 7.0, IQR 7-7; mean 6.9, SD 0.45), expressing willingness to use it daily (median 7.0, IQR 7-7; mean 6.9, SD 0.31), and indicating trust in the system (median 7.0, IQR 7-7; mean 6.9, SD 0.32) on a 7-point Likert scale (1=worst; 7=best). Clinician usability was supported by podiatrist review of 3295 scans, of which 3220 (97.7%) were rated as usable for clinical assessment. Three representative cases illustrated real-world device use and longitudinal image review, demonstrating the ability to visualize skin changes such as foreign body presence, new ulceration, and early skin breakdown.

CONCLUSIONS

This retrospective formative evaluation 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 usability in 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 health care use.