Novel Technology Can Detect Emergence of Foot Ulcers in Diabetes Patients

A new monitoring technology may be able to detect emerging foot ulcers prior to presentation among patients with diabetes, according to a study published by Diabetes Care.

The study authors reported that the Podimetrics SmartMat detected nearly all developing nontraumatic plantar foot ulcers prior to clinical presentation among patients.

The investigators found that 86% of patients used the mat at least 3 times per week and 88% reported it was easy-to-use, according to the study. These findings suggest that patients may widely accept the novel technology.

“The Podimetrics Remote Temperature Monitoring System could have huge benefits for patients with diabetes who are at high risk by significantly reducing morbidity and mortality associated with diabetic foot ulcers, which could also lead to improvements in resource utilization,” said lead investigator Robert Frykberg, DPM.

Included in the study were 129 patients with diabetes and prior foot ulcers who evaluated the Podimetrics Remote Temperature Monitoring System.

The primary outcome was the development on nontraumatic diabetic foot ulcers, according to the study. The primary efficacy analysis was the accuracy of the SmartMat to detect emerging foot ulcers over multiple temperature asymmetry thresholds.

At a temperature asymmetry threshold of 2.22° C—the standard threshold used in plantar thermometry studies—the SmartMat correctly identified 97% of foot ulcers, with an average time of 37 days before clinical presentation, according to the study.

By increasing the temperature to 3.20° C, the authors discovered that sensitivity was reduced to 70%, but the false positive rate dropped nearly 20% with the same lead time.

“The false positive rate observed in this study was not surprising or concerning,” Dr Frykberg said. “This is particularly true given that the value of preventing a foot ulcer and its complications far outweighs the nuisance factor of a false alert. In a real-world setting, when a doctor gets a notification that a patient has a hotspot, the patient will be advised to reduce physical activity for a period to let the developing wound heal or may be asked to come in for a visit in serious cases. Even at the most sensitive setting presented in the study, these results translate to only 3.1 total notifications to the physician and patient per year, including all true and false positives.”

The system works by notifying patients and physicians at the sign of inflammation. Patients are instructed to stand on the SmartMat for 20 seconds per day to determine temperature differences between locations of the foot, indicating “hotspots.”

Previous research has indicated that hotspots often lead to the development of a foot ulcer. If the ulcer does not heal, it can lead to significant adverse events, including amputation in some cases.

Since the Podimetrics SmartMat was able to detect potential hotspots 5 weeks in advance of clinical presentation, patients may be able to prevent the development of the ulcers.

“These data reinforce our belief that the Podimetrics Remote Temperature Monitoring System, which consists of a wireless SmartMat for the home and a full monitoring and notification service, may allow earlier detection of DFU and significant improvements in care,” said Jon Bloom, MD, CEO of Podimetrics. “When we developed our system, it was clear that patients wanted an easy-to-use, in-home solution. This study demonstrates that patients find the Podimetrics SmartMat easy-to-use and that 86% of the population used it at least 3 times per week on average - which is critical for adherence and ultimately achieving ongoing prevention of DFU and its devastating complications.”