Robert G Frykberg1, Ian L Gordon2, Alexander M Reyzelman3, Shawn M Cazzell4, Ryan H Fitzgerald5, Gary M Rothenberg6, Jonathan D Bloom7, Brian J Petersen7, David R Linders7, Aksone Nouvong8, Bijan Najafi9,10. 1. Phoenix VA Health Care System, Phoenix, AZ robert.frykberg@va.gov. 2. VA Long Beach Healthcare System, Long Beach, CA. 3. Center for Clinical Research, Castro Valley, CA. 4. Limb Preservation Platform Inc., Fresno, CA. 5. Greenville Health System, Greenville, SC. 6. University of Michigan, Ann Arbor, MI. 7. Podimetrics, Inc., Somerville, MA. 8. VA Greater Los Angeles Healthcare System, Los Angeles, CA. 9. University of Arizona, Tucson, AZ. 10. Baylor College of Medicine, Houston, TX.
Abstract
OBJECTIVE: We conducted a multicenter evaluation of a novel remote foot-temperature monitoring system to characterize its accuracy for predicting impending diabetic foot ulcers (DFU) in a cohort of patients with diabetes with previously healed DFU. RESEARCH DESIGN AND METHODS: We enrolled 132 participants with diabetes and prior DFU in this 34-week cohort study to evaluate a remote foot-temperature monitoring system (ClinicalTrials.gov Identifier NCT02647346). The study device was a wireless daily-use thermometric foot mat to assess plantar temperature asymmetries. The primary outcome of interest was development of nonacute plantar DFU, and the primary efficacy analysis was the accuracy of the study device for predicting the occurrence of DFU over several temperature asymmetry thresholds. RESULTS: Of the 129 participants who contributed evaluable data to the study, a total of 37 (28.7%) presented with 53 DFU (0.62 DFU/participant/year). At an asymmetry of 2.22°C, the standard threshold used in previous studies, the system correctly identified 97% of observed DFU, with an average lead time of 37 days and a false-positive rate of 57%. Increasing the temperature threshold to 3.20°C decreased sensitivity to 70% but similarly reduced the false-positive rate to 32% with approximately the same lead time of 35 days. Approximately 86% of the cohort used the system at least 3 days a week on average over the study. CONCLUSIONS: Given the encouraging study results and the significant burden of DFU, use of this mat may result in significant reductions in morbidity, mortality, and resource utilization.
OBJECTIVE: We conducted a multicenter evaluation of a novel remote foot-temperature monitoring system to characterize its accuracy for predicting impending diabetic foot ulcers (DFU) in a cohort of patients with diabetes with previously healed DFU. RESEARCH DESIGN AND METHODS: We enrolled 132 participants with diabetes and prior DFU in this 34-week cohort study to evaluate a remote foot-temperature monitoring system (ClinicalTrials.gov Identifier NCT02647346). The study device was a wireless daily-use thermometric foot mat to assess plantar temperature asymmetries. The primary outcome of interest was development of nonacute plantar DFU, and the primary efficacy analysis was the accuracy of the study device for predicting the occurrence of DFU over several temperature asymmetry thresholds. RESULTS: Of the 129 participants who contributed evaluable data to the study, a total of 37 (28.7%) presented with 53 DFU (0.62 DFU/participant/year). At an asymmetry of 2.22°C, the standard threshold used in previous studies, the system correctly identified 97% of observed DFU, with an average lead time of 37 days and a false-positive rate of 57%. Increasing the temperature threshold to 3.20°C decreased sensitivity to 70% but similarly reduced the false-positive rate to 32% with approximately the same lead time of 35 days. Approximately 86% of the cohort used the system at least 3 days a week on average over the study. CONCLUSIONS: Given the encouraging study results and the significant burden of DFU, use of this mat may result in significant reductions in morbidity, mortality, and resource utilization.
Authors: Kristin L Schneider; Ryan T Crews; Vasanth Subramanian; Elizabeth Moxley; Sungsoon Hwang; Frank E DiLiberto; Laura Aylward; Jermaine Bean; Sai Yalla Journal: J Diabetes Sci Technol Date: 2019-01-18
Authors: N L Petrova; A Whittam; A MacDonald; S Ainarkar; A N Donaldson; J Bevans; J Allen; P Plassmann; B Kluwe; F Ring; L Rogers; R Simpson; G Machin; M E Edmonds Journal: J Foot Ankle Res Date: 2018-05-30 Impact factor: 2.303
Authors: Trisha Shang; Jennifer Y Zhang; B Wayne Bequette; Jennifer K Raymond; Gerard Coté; Jennifer L Sherr; Jessica Castle; John Pickup; Yarmela Pavlovic; Juan Espinoza; Laurel H Messer; Tim Heise; Carlos E Mendez; Sarah Kim; Barry H Ginsberg; Umesh Masharani; Rodolfo J Galindo; David C Klonoff Journal: J Diabetes Sci Technol Date: 2021-07