Effectiveness of a Continuous Remote Temperature Monitoring Program to Reduce Foot Ulcers and Amputations: Multicenter Postmarket Registry Study

Abstract

Background Neuropathic foot ulcers are the leading cause of nontraumatic foot amputations, particularly among patients with diabetes. Traditional methods of monitoring and managing these patients are periodic in-person clinic visits, which are passive and may be insufficient for preventing neuropathic foot ulcers and amputations. Continuous remote temperature monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions. For the first time, the effectiveness of such a strategy to prevent neuropathic foot ulcers and related complications among high-risk patients in a real-world commercial setting is reported. Objective This study aims to evaluate the effectiveness of a real-world continuous remote temperature monitoring program in preventing neuropathic foot ulcers and amputations in patients with diabetes. Methods In this retrospective analysis of a real-world continuous remote temperature monitoring program, 115 high-risk patients identified by clinical providers from 15 geographically diverse private podiatry offices were analyzed. Patients received continuous remote monitoring socks as part of the program. The enrollment was based on medical necessity as decided by their managing physician. We evaluated data from up to 2 years before enrollment and up to 3 years during the program. The primary outcome was the rate of wound development. Secondary outcomes included amputation rate, the severity of the foot ulcers, and the number of visits to an outpatient podiatry clinic after enrolling in the program. Results We observed significantly lower rates of foot ulceration (relative risk reduction [RRR] 0.68; 95% CI 0.52-0.79; number needed to treat [NNT] 5.0; P<.001), less moderate to severe ulcers (RRR 0.86; 95% CI 0.70-0.93; NNT 16.2; P<.001), less amputations (RRR 0.83; 95% CI 0.39-0.95; NNT 41.7; P=.006), and less hospitalizations (RRR 0.63; 95% CI 0.33-0.80; NNT 5.7; P<.002). We found a decrease in outpatient podiatry office visits during the program (RRR 0.31; 95% CI 0.24-0.37; NNT 0.46; P<.001). Conclusions Our findings suggested that a real-world continuous remote temperature monitoring program was an effective strategy to prevent foot ulcer development and nontraumatic foot amputation among high-risk patients.