Temperature Monitoring Clinical Trials
Multiple studies have shown the efficacy of temperature monitoring to manage foot health.
Foundational Studies
Home Monitoring of Foot Skin Temperatures to Prevent Ulceration
Published 2004
Diabetes Care
[A]t-home patient self-monitoring with daily foot temperatures may be an effective adjunctive tool to prevent foot complications in individuals at high risk for lower-extremity ulceration and amputation. (...) The enhanced therapy group had significantly fewer diabetic foot complications (enhanced therapy group 2% vs. standard therapy group 20%, P = 0.01, odds ratio 10.3, 95% CI 1.2-85.3).
Published 2007
Diabetes Care
Infrared temperature home monitoring, in serving as an "early warning sign," appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations. (...) The enhanced therapy group had fewer foot ulcers than the standard therapy and structured foot examination groups (enhanced therapy 8.5 vs. standard therapy 29.3%, P = 0.0046 and enhanced therapy vs. structured foot examination 30.4%, P = 0.0029). Patients in the standard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group.
Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-Risk Patients
Published 2008
The American Journal of Medicine
High temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration. (...) Subjects were one third as likely to ulcerate in the Dermal Thermometry Group compared with the Standard Therapy Group (12.2% vs 4.7%, odds ratio 3.0, 95% confidence interval, 1.0 to 8.5, P=.038). (...) [T]hermometry intervention was associated with a significantly longer time to ulceration (P=.04)
Peer-reviewed Publications
Published 2024
Journal of Medical Internet Research
[R]eal-world continuous remote temperature monitoring program was an effective strategy to prevent foot ulcer development and nontraumatic foot amputation among high-risk patients. (...) [The study] observed significantly lower rates of foot ulceration, less moderate to sever ulcers, less hospitalizations (...) [and] a decrease in outpatient podiatry office visits during the program.
Published 2022
Journal of Medical Internet Research Formative Research
This study shows a high level of utilization for a smart sock RPM device and a high compliance rate. (...) The average number of days that the socks were worn per week was 5.8. The percentage of patients with a utilization rate of >15 days ranged from 79.7% (106/133) to 91.9% (125/136) each month.
Published 2022
Journal of Medical Internet Research Formative Research
A significant difference in temperature differential (...) was observed in the group that presented with a podiatric injury over the course of evaluation versus the comparator group that did not present with a podiatric injury. (...) [T]emperature monitoring in a sock form factor could be used to predict a developing foot injury.
Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study
Published 2018
Journal of Medical Internet Research
The wearers found the socks to be no different from standard socks. The temperature studies conducted show that the sensors used in the socks are reliable and accurate at detecting temperature and the findings matched clinical observations.