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Evidence is lacking for the benefit of newer remote patient pedal monitoring devices designed to prevent foot ulcers among at-risk individuals, although older model hand-held thermometers show a small benefit on ulcer incidence. Current evidence does not demonstrate consistent reductions in amputation, hospitalization, or mortality for any such devices. Ongoing trials may provide needed guidance on the clinical value of remote patient pedal monitoring technology to improve outcomes for Veterans.
Foot ulcers are a significant source of morbidity among individuals with predisposing conditions such as diabetes, peripheral neuropathy, and peripheral arterial disease. Early signs of ulcer development can go unnoticed due to loss of protective sensation. Remote patient pedal monitoring devices, including hand-held thermometers, temperature-sensing mats, socks, and pressure-monitoring insoles, have been proposed as tools to support detection of early physiological changes associated with ulcer formation. We aimed to evaluate the effectiveness and safety of remote patient pedal monitoring devices designed to detect early signs of foot ulceration among high-risk adults.
Remote patient pedal monitoring for the prevention of foot ulcers among high-risk individuals was evaluated across 12 comparative studies. Among the 6 hand-held thermometry trials, a small rate difference in ulcer incidence was observed equating to a 50% relative reduction in ulceration compared to standard of care (95% CI [70% to 3%]). There is little trial-based data on effect of newer temperature sensing devices with remote transmission of data, though 2 observational studies suggest possible benefit Pressure-based monitoring was only assessed in 1 small, randomized trial with inconclusive results. The limited evidence for amputation, hospitalization, and mortality was mixed. Device adherence varied widely across studies and was often low, limiting conclusions. The studies included found no consistent effect among those with greater adherence. No literature comparing outcomes by device type, monitoring frequency, or feedback method was identified.
Remote Patient Pedal Monitoring for Foot Ulcer Prevention: A Systematic Review (Management Brief)
