Diabetes Research Programme - DM14

Implementation of foot thermometry and SMS to prevent diabetic foot ulcer

Project Locations: Lima, Perú

Funding organisation(s)

• National Institutes of Health, USA
• Fogarty International Center, USA

Primary research aim

Compare the incidence of diabetic foot ulcer (DFU) during the study between the arm that receives thermometry alone and the arm that receives thermometry + SMS.

Secondary research aims

Compare compliance with foot thermometer use between the thermometry alone arm and the arm that receives thermometry + SMS.

Research objectives and methodology

Objectives

1. Compare the incidence of DFU during the study between the arm that receives thermometry alone and the arm that receives thermometry + SMS. We hypothesize that subjects who receive SMS will have a lower incidence of DFU than the subjects who do not receive SMS.
2. Compare compliance with foot thermometer use between the two arms. We hypothesize that subjects who receive SMS will be more compliant with temperature measurement.

Design

Physician-blinded, randomized, 12-month trial.

Intervention

Participants in both groups will receive enhanced education about diabetic foot ulcer at the beginning of the study and will also be provided with TempStat, equipment that capture a thermal image of feet with different colors that represent different temperatures, when a yellow spot is detected, subjects will be instructed to contact the research nurse by phone or text message. She or he will then ask about the patient’s activity on the previous two days, and will then make recommendations on how to decrease activity. In addition to everything provided to the other intervention group, this enhanced intervention arm will receive SMS reminders via mobile phones five times a week at 12 o ́clock during the first week and then 2 times a week until the end of the trial. These SMS will remind patients to use the TempStat and perform foot care.

Outcome

The primary outcome is foot ulceration occurring at any point during the 12 month study duration.

Project contact: Maria Lazo - maria.lazo@upch.pe

Investigators

• Jaime Miranda, Universidad Peruana Cayetano Heredia, Lima, Peru
• Antonio Bernabe-Ortiz, Universidad Peruana Cayetano Heredia, Lima, Peru
• German Malaga, Universidad Peruana Cayetano Heredia, Lima, Peru
• Maria Lazo, Universidad Peruana Cayetano Heredia, Lima, Peru
• Katherine Sacksteder, John Hopkins University, Baltimore, USA
• Prof Robert Gilman, John Hopkins University, Baltimore, USA

Links

Clinical trial record

Publications

Lazo-Porras, M., Bernabe-Ortiz, A., Sacksteder, K. A., Gilman, R. H., Malaga, G., Armstrong, D. G., & Miranda, J. J. (2016). Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial. Trials, 17(1), 1-10. doi:10.1186/s13063-016-1333-1