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Diabetes mellitus is one of the most common diseases around the world, and mainly affects the foot among the human body parts. The main causes of the diabetic foot are neuropathy, peripheral arterial disease and foot deformities; it leads to foot ulceration. Generally, sensory loss, high plantar pressure, foot deformities, inappropriate footwear, blindness, and age are the causing risk factors for developing foot ulceration in diabetic patients. Foot ulceration will result in prolonged hospitalization, high medical expenses, and serious complications with lower extremity amputation. For a long time, appropriate footwear has been recommended by physicians for reducing plantar pressure to prevent foot ulceration, the risk of amputation, and re-ulceration. A review is provided in this article towards the existing literature on the causes and prevalence of the diabetic foot, foot ulceration, off-loading pressure, footwear modification for different types of diabetic foot deformities, and types of footwear and textile materials used in footwear insoles for healing purposes.

The purpose of this paper is to develop a prototype of a wearable medical device in the form of a bandage with a real-time data monitoring platform, which can be used domestically for diabetic patients to identify the possibility of foot ulceration at the early stage.

The prototype can measure blood volumetric change and temperature variation in the forefoot area simultaneously. The waveform extracted using a pulsatile-blood-flow signal was used to assess blood perfusion-related information, and hence, predict ischemic ulcers. The temperature difference between ulcerated and the reference was used to predict neuropathic ulcers. The medical device can be used as a bandage during the application wherein the sensory module is placed inside the hollow pocket of the bandage. A platform was developed through a mobile application where doctors can extract real-time information, and hence, determine the possibility of ulceration.

The height of the peaks in the pulsatile-blood-flow signal measured from the subject with foot ischemic ulcers is significantly less than that of the subject without ischemic ulcers. In the presence of ischemic ulcers, the captured waveform flattens. Therefore, the blood perfusion from arteries to the tissue of the forefoot is considerably low for the subject with ischemic ulcers. According to the temperature difference data measured over 25 consecutive days, the temperature difference of the subject with neuropathic ulcers occasionally exceeded the 4 °F range but mostly had higher values closer to the 4 °F range. However, the temperature difference of the subject who had no complications of neuropathic ulcers did not exceed the 4 °F range, and the majority of the measurements occupy a narrow range from −2°F to 2 °F.

The proposed prototype of wearable medical apparatus can monitor both temperature variation and pulsatile-blood-flow signal on the forefoot simultaneously and thereby predict both ischemic and neuropathic diabetes using a single device. Most importantly, the wearable medical device can be used domestically without clinical assistance with a real-time data monitoring platform to predict the possibility of ulceration and the course of action thereof.