Resumen de Impulse, a wearable in-shoe temperature and pressure system to monitor the diabetic high-risk foot
Introduction: To date, ulcer prevention and recurrence relies on offloading the previously ulcerated on high pressure areas based on visual observation and clinical experience. The design and development of an innovative, in-shoe, single sensor, pressure and temperature monitoring device - IMPULSE will be presented in this communication. What inspired the development of this device is to provide a compact, low-cost and efficient alternative device which is able to pre-empt the development of diabetic foot ulceration through the measurement of in-shoe plantar pressures and skin temperatures simultaneously, as opposed to current costly commercial technologies. The aim of this study was to compare the outcome of incorporating IMPULSE as an adjunct to standard clinical protocols versus relying on the standard protocol on its own for wound monitoring and manufacture of orthoses.
Patients and methods: A matched parallel, prospective experimental study included 88 participants living with Type 2 diabetes mellitus and a past history of plantar foot ulceration and prescribed orthoses was conducted. Participants were randomly divided into 2 groups, the control group (n = 44) received standard care only. The experimental group (n = 44) were assessed with the innovative device for peak pressure areas and peak temperature whilst still receiving standard care. Both groups were monitored for re-ulceration every 4 months for a period of 1 year.
Results: A higher number of cases of ulcer healing was noted in experimental group implying that the use of IMPULSE as an adjunct to the standard diabetic footcare resulted in better outcomes compared to standard diabetic foot care alone. Furthermore, a correlation between in-shoe skin temperature and in-shoe peak plantar pressure was confirmed.
Conclusions: This study highlights the need for more objective clinical decision making in the treatment and management of the diabetic high-risk foot. Moreover, a correlation between in-shoe foot temperature and pressure parameters, in different scenarios such as walking with and without orthoses, in view of tissue breakdown was confirmed. The ultimate goal of such a device is to preserve functional lower limbs.
