Remote Patient Pedal Monitoring for Foot Ulcer Prevention: A Systematic Review

The report is a product of the VA/HSR Evidence Synthesis Program.

Remote Patient Pedal Monitoring for Foot Ulcer Prevention: A Systematic Review

Takeaway: Foot ulcers-physical deterioration of skin that results in an open wound-are prevalent among Veterans and are associated with serious complications. This review found that definitive evidence is lacking regarding the effectiveness of newer model remote patient pedal monitoring devices (tools that identify early physiologic changes amenable to preventative action) to prevent foot ulcers, although older hand-held temperature-sensing models without remote data transmission showed a small reduction in ulcer incidence. Evidence does not demonstrate that remote patient pedal monitoring devices consistently reduce amputation, hospitalization, or mortality. Ongoing trials may provide needed guidance on the clinical value of remote patient pedal monitoring technology.

Foot ulcers-physical deterioration of skin that results in an open wound-are prevalent among Veterans and are a significant source of morbidity among those with predisposing conditions such as diabetes, peripheral neuropathy, and peripheral arterial disease. Foot ulcers are associated with a range of serious complications including infection, lower extremity amputation (LEA), and decreased quality of life. Because early signs of ulcer development can go unnoticed due to loss of sensation and other factors, frequent monitoring and close inspection are critical for early detection of tissue damage and prevention of ulcer development. Remote patient pedal monitoring devices (tools that assess early physiologic changes in the feet, e.g., hand-held thermometers, temperature-sensing mats, socks, and pressure-monitoring insoles) with and without data transmission to clinical teams have been proposed as tools to reduce access barriers and support detection of early physiological changes associated with ulcer formation in high-risk patients.

HSR's Evidence Synthesis Program ( ESP ) Center in Durham, NC, reviewed the scientific literature to evaluate the effectiveness and safety of remote patient pedal monitoring devices designed to detect early signs of foot ulceration among high-risk adults. The ESP investigators also sought to determine if device benefits vary by device type and by certain patient characteristics. The ESP team searched MEDLINE, CINAHL, and other sources from inception to May 5, 2025, for relevant studies.

Summary of Findings

• ESP investigators identified 12 relevant studies (9 randomized controlled trials [RCTs], 3 observational studies). Eleven studies evaluated temperature-based monitoring; one study assessed pressure monitoring. Device types included hand-held thermometers, standing mats, socks, and insoles.
• Six trials of older hand-held thermometer devices without automatic remote data transmission showed a small absolute reduction in ulcer occurrence equating to a 50% relative reduction in ulceration compared to standard of care.
• There is little trial-based data for newer temperature-monitoring devices with remote transmission of data, although two observational studies suggest a possible benefit.
• Pressure-based monitoring was assessed only in one small, randomized trial with inconclusive results.
• Evidence for amputation, hospitalization, and mortality was limited and mixed.
• Device adherence varied widely across studies and was often low.
• The studies found no consistent effect among patients with greater adherence.
• No literature compared outcomes by device type, monitoring frequency, or feedback method.
• Collectively, the strength of evidence across ulceration, LEA, hospitalization, and mortality outcomes was generally very low or insufficient due to the limited number of studies, small sample sizes, heterogeneity of effect estimates, device and population differences, and inconsistent definitions.

Implications

Given the many Veterans at risk of foot ulcers and subsequent LEA, the potential benefit of remote patient pedal monitoring devices, which are non-invasive, low-risk interventions, may justify their continued use in clinical practice. If currently marketed remote patient pedal monitoring devices are found to be effective under controlled trial conditions, it will be crucial to determine how to boost patients' adherence, as real-world evidence shows uneven uptake among patient subpopulations.

Limitations

Limitations of this review include the available data in the published literature, as well as the variability across population demographics, monitoring device type, outcome definitions, and length of follow-up. Only eight studies evaluated adherence, and approaches to evaluate adherence varied. In addition, patient populations at risk for ulceration differed across studies.

Future Research

While four ongoing trials might fill some evidence gaps on remote patient pedal monitoring, future research should address existing evidence limitations by using consistent definitions of ulcer outcomes, standardized eligibility criteria for identifying high-risk populations, and objective adherence measures. Studies should also evaluate newer devices with automated feedback or continuous monitoring features that may improve usability and sustained engagement. Research conducted within VA is needed to assess how remote patient pedal monitoring integrates with existing preventive care workflows, and to enhance understanding of patient preferences, staff workload implications, and long-term clinical outcomes. Additional work is also needed to evaluate potential cost savings, system-level benefits, and strategies for sustaining device use over time.

Citation:

Brooks KR, Der T, Alishahi Tabriz A, Crossgrove R, et al. Remote Patient Pedal Monitoring for Foot Ulcer Prevention: A Systematic Review. Washington, DC: Evidence Synthesis Program, Health Systems Research, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-010; 2026.

To view the full report, go to vaww.hsrd.research.va.gov/publications/esp/remote-monitoring.cfm (This report is available via intranet only.)