Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial

Abstract

BackgroundDiabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period.Methods/designThis is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18–80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru.Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care.Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study.DiscussionThis study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.Trial registrationThis study is registered in ClinicalTrials.gov: Identifier NCT02373592.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1333-1) contains supplementary material, which is available to authorized users.

Current State of Diabetes Mellitus Prevalence, Awareness, Treatment, and Control in Latin America: Challenges and Innovative Solutions to Improve Health Outcomes Across the Continent

“…In addition, a non-exhaustive list of examples of past or current interventions, policies, and initiatives is provided in Table 4 [184,186,234,[236][237][238][239][240][241][242][243][244][245][246][247][248][249][250][251][252]. Interventions in the list include tele-ophthalmology [249,250,253,254], teambased foot self-care education [236], diabetic retinopathy education and screening at a community pharmacy [255], rapid assessment/diagnostic tools to screen for or detect retinopathy, nephropathy, and risk of developing foot ulcers [201,[256][257][258][259][260][261][262] and are examples of clinical research and/or implementation activities designed to strengthen the prevention and early detection of diabetes-associated complications and improve health outcomes throughout LatAm.…”

Telehealth and telemedicine applications for the diabetic foot: A systematic review

“…Finally, apart from local cost calculations of foot complications, no data have been published on the cost‐effectiveness of dermal thermography. Well‐designed trials are currently underway to investigate cost‐effectiveness and usability …”

“…Well-designed trials are currently underway to investigate costeffectiveness and usability. 81,84 Regarding liquid-crystal thermography, only three small clinical studies were found on the prediction of ulceration 38,39 and diagnosis of foot complications. 40 While liquid-crystal thermography is easy to use and gives temperature patterns of the entire foot, interpretation of the data can be difficult, and since the year 2000, no studies have been published on the use of liquid-crystal thermography in the diabetic foot, suggesting a limited applicability.…”

All Feet on Deck: The Role of Podiatry During the COVID-19 Pandemic: Preventing Hospitalizations in an Overburdened Health-Care System, Reducing Amputation and Death in People with Diabetes

“…RPM through temperature sensing devices meets CMS guidelines for a physiologic measure and has robust data as an early warning system for diabetic foot ulcers in high-risk patients. [23][24][25][26] These patients were typically seen in podiatry offices every 2 to 6 months for preventative visits to reassess changes and risk for ulceration, but with RPM could be pushed out longer and the podiatrist notified when a problem is imminent. CMS has also allowed for reimbursement for RPM in many circumstances.…”