This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration (subjects with a previous ulcer or minor amputation or deformities +neuropathy). Specific Aims are: (1) Compare the incidence of diabetic foot ulceration during the study between the arm that receives thermometry alone and the arm that receives thermometry plus SMS and voice messaging. (2) Compare the compliance with foot thermometer use between the two study arms.
Physician-blinded, randomized, 12-month trial.
Placebo Comparator: Thermometry-only group. Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet through colors. Some alarm signs have been pre-specified: 1) When the thermal image shows yellow spots in any area of any feet for two consecutive days, 2) when the thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion is detected at any time. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone or text message. For the first two types of alarm signs, once the study nurse is contacted he/ she will ask about the presence of lesions in the patient’s feet and the patient’s activity on the previous two weeks, and will provide recommendations on how to decrease activity until temperatures normalize. If TempStat measurements continue to show alarm signs for more than one week after the telephone consultation, the participant will be asked to contact the nurse and schedule a face-to-face evaluation to assess the presence of an infection and/or ulcer with a masked assessor. In the third type of alarm sign, presence of a dermal lesion, participants will be asked to contact the study’s nurse and he/she will make an appointment for an evaluation with a nurse blind to the intervention.
Experimental: Thermometry plus SMS and voice messaging Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat and messages to promote foot care.
María Lazo Porras
Fogarty International Center – National Institute of Health
J Jaime Miranda, MD, MsC, PhD
Antonio Bernabe Ortiz, MD, MPH
Robert H. Gilman, MD, DTMH
Katherine Sacksteder, PhD
Germán Malága, MD
María Lazo Porras, MD
David Armstrong, DPM, MD, PhD