Diabetic foot disease (DFD) is a major complication of diabetes in which structural or functional changes in the foot occur may be an alternative owing to diabetic neuropathy, peripheral vascular disease-related ulcers, infections, gangrene, and malformations (van Netten et al., 2020). DFD can also occur because of the interaction between persistent hyperglycemia and previous traumatic causes, even if there is no foot lesion (Jeong, Jeong, & Kim, 2005). DFD has been reported to occur in approximately 3–13 % of patients with diabetes (Zhang et al., 2017). Symptoms begin with foot pain and reduced thermesthesia and progress to decreased vibration sensitivity and surface contact, resulting in a state wherein no mechanical, chemical, or thermal stimulation is felt. This factor increases gait disturbance, instability, and the risk of falls. Several previous studies have reported that diabetic neuropathy and active foot ulcers are major factors among the risk factors for falls in patients with DFD (Allen, Powell-Cope, Mbah, Bulat, & Njoh, 2017; Bokan-Mirković, Škarić-Karanikić, Nejkov, Vuković, & Ćirović, 2017; Pinheiro, Vilaça, & de Azevedo Carvalho, 2015). Patients with diabetic neuropathy were reported to have a 2.3 times higher risk of falling than patients with diabetes without diabetic neuropathy (Khan et al., 2021) and 20 times higher than those without diabetes (Reeves, Brown, Petrovic, Boulton, & Vileikyte, 2017). In addition, patients with DFD are twice as likely to have a fall risk and three times as likely to develop a fracture due to falling compared to those without (Allen et al., 2017).

Falls negatively affect not only the physical injury but also the emotional state and cause fear of falling (FOF) even if no severe damage has occurred because of the fall (Vongsirinavarat, Mathiyakom, Kraiwong, & Hiengkaew, 2020). Patients with high FOF limit their functions and fail to perform normal activities, resulting in greater dysfunction, which may lower the quality of life (de Souza Moreira et al., 2017). FOF can appear regardless of the fall experience and can also be a risk factor for falls. Owing to the cyclical relationship between falls and FOF, their related factors are similar. Factors related to falls and FOF in patients with DFD reported in previous studies include demographic characteristics such as age (old age), sex (female), marital status (de Souza Moreira et al., 2017), and low body mass index (Pinheiro et al., 2015); disease-related characteristics such as diabetic neuropathy, poor diabetes control, diabetic complications, advanced disease status, foot and body pain, duration of diabetes (Bokan-Mirković et al., 2017), and pharmacological complications (de Souza Moreira et al., 2017); fall-related factors such as visual impairment, hearing impairment, balance impairment (Vongsirinavarat et al., 2020), muscle weakness, increased postural sway, and gait and mobility impairments (Reeves, Orlando, & Brown, 2021); and psychological factors such as depression (de Souza Moreira et al., 2017).

Patients with DFD are at high risk for severe injuries because of various potential risks of a foot injury. Therefore, early assessment of modifiable risk factors is essential to prevent secondary injuries due to falls and FOF. Hence, screening the foot health condition, such as foot pain characteristics, claw conditions, foot skin conditions, foot formation, and pulse, in patients with DFD using bed-side observation and simple tools by nurses can help identify patients at high risk of falls and FOF early and initiate protective measures. As described above, according to previous studies, foot pain and the health status of patients with DFD are expected to be related to falls and FOF. However, literature on the relationship between these factors and falls/FOF is limited. These articles are reviews (Reeves et al., 2021) or studies targeting patients with diabetic neuropathy (Pinheiro et al., 2015). They have reported that decreased foot sensitivity and increased pain in patients with diabetic neuropathy increase the risk of falls (Bokan-Mirković et al., 2017). However, as previous studies were conducted only on patients with diabetic neuropathy, there are limitations in understanding the relationship between foot pain and health status and falls/FOF in patients with DFD.

Thus, this study aimed to establish the rationale for developing effective interventions to prevent falls by determining falls, FOF, and related factors in patients with DFD.