The quest for wellness: How to optimise self‐care strategies for diabetic foot management?

Diabetic foot ulceration (DFU) is common and highly recurrent, negatively impacting the individuals' quality of life. The 2023 guidelines of the International Working Group on the Diabetic Foot emphasise that adherence to foot self‐care recommendations is one of the most important factors in DFU prevention. These guidelines also briefly mention that depression and other psychosocial problems can hamper treatment and ulcer healing. Moreover, a new clinical question was added on psychological interventions for ulcer prevention, although the evidence regarding the role of psychological and social factors is still limited. To help the field progress, this narrative overview discusses how a stronger focus on psychological factors by both researchers and clinicians could improve the care for people at high DFU risk. The review starts with a testimony of a person living with DFU, explaining that for him, the absence of shared decision‐making has been a key barrier to successful foot self‐care implementation. Intervention studies that address patient‐reported barriers are still scarce, and are therefore urgently needed. Furthermore, the key elements of psychological interventions found to be successful in managing diabetes are yet to be implemented in DFU risk management. Importantly, research evidence indicates that commonly advocated foot self‐care recommendations may be insufficient in preventing DFU recurrence, whereas digital technology appears to effectively reduce recurrent DFU. More research is therefore needed to identify determinants of patient acceptance of digital technology.

self-care and structured education have not been studied adequately. 2 Furthermore, while recognising the potential role of psychological interventions in DFU prevention, a recommendation about the use of such interventions for DFU prevention was not made due to a very low evidence base. 1 This review opens with the views of Andy Lavender, a person living with diabetes foot complications, who addressed the question of adherence to foot self-care from a personal perspective.Next, we overview the psychological barriers that hamper optimal foot selfcare.We also describe the key elements of psychological interventions that could potentially improve DFU outcomes.We review the body of evidence emerging from clinical and digital technology research along with that from psychological interventions.Finally, in view of increasing evidence suggesting that digital technologies are promising in reducing DFU occurrence, we discuss the additional layers of complexity these technologies introduce to foot self-care.

| ADHERENCE TO FOOT SELF-CARE THROUGH THE LENS OF A PERSON WITH DIABETES
"The biggest part to me of taking the advice given to me is involving me in the decision-making process and letting me make that final decision.Let's take Charcot Foot and an off-loading boot: what does that mean to the person and not the patient?Look at the options of the person: -is there a boot that will offload yet allows them to go to work in some reduced capacity?For me being asked what was important to me and what my goals were was the key.Yes, I wanted my foot to get better, but I also wanted my mental health to be in a good place so being able to go out even for a short walk in a boot that meant I could walk yet still protect the foot for me played a huge part in my compliance.Thus, if you involve the person and work with them to meet their goals, they are more likely to follow that treatment.It

must be my choice, my decision and for me my clinical team knows what's important to me, they know what my goals are
what I want to achieve so we work together as a team".Thus, there are three pillars on which people with diabetes build their adherence decisions: (1) do not simply "prescribe" offloading device but, if you wish the person to adhere/wear it, explore the person's preferences and perceptions regarding the offloading device; (2) make sure to involve the person in decision-making regarding his/her treatment and (3) let the person make the informed, final decision.

| PSYCHOLOGICAL BARRIERS THAT IMPAIR FOOT SELF-CARE
In a systematic review with meta-analysis into the health-related quality of life (HR-QoL) of people with a DFU, 12 studies were included. 3It was concluded that the HR-QoL of these individuals was poor on four of the eight subscales of the SF-36: Physical role limitations, General health, Physical functioning and Vitality. 36][7] In a 5-year follow-up of people with a first DFU, the prevalence of diagnosed depressive disorder at baseline was 32% and those with a diagnosed depressive disorder at baseline appeared to have a twofold increased risk of mortality. 8Detailed analyses showed an increased mortality risk not only for those with a major depressive disorder [hazard ratio (HR) 2.18, 95% CI 1.31, 3.65] but also for those with minor depression (HR 1.93, 95% CI 1.00, 3.74), compared with DFU patients who were not depressed. 8 an insightful systematic review of qualitative research, Coffey et al. have explored the perceptions of individuals with diabetes and experiences of DFU in order to identify how they could be better supported to prevent ulceration or manage its impact. 9It was found that lack of knowledge and participants' beliefs and perceptions regarding DFU causation often conflicted with conventional medical understanding of this condition, for example, in case of misguided attempts to increase circulation by walking barefoot or wearing open-toed sandals. 9Participants also explained that they had been either unaware of, or unconcerned about, their risk of DFU. 9 Some believed that DFU and amputation only occurred in acute cases or only in case of poor hygiene and were critical of individuals who neglected themselves to such an extent. 9Even when knowledge of appropriate foot care behaviours was present, perceived barriers, such as their negative impact on everyday activities, precluded adherence. 9The lack of visible symptoms and gradual onset of this "silent disease" provided few cues for action, leading them to become complacent.Foot self-care was often considered of lower priority than more immediate demands (e.g.taking medication, monitoring blood glucose levels). 9Physical and cognitive limitations, such as poor eyesight, problems remembering, or difficulty reaching feet, also posed challenges in performing foot self-care. 9Factors that appeared to motivate engagement in foot self-care included receipt of education and/or training from health care professionals.Many individuals expressed frustration with wearing the prescribed footwear and other orthotic devices, which were found to be expensive and uncomfortable, with unattractive appearance of therapeutic footwear also mentioned. 9Health professionals' communication with participants regarding DFU and foot care was frequently considered to be poor. 9In particular, individuals who underwent diabetes-related amputation often remarked on the insensitivity of consultants in disclosing their need for this procedure.Many commented on the paternalistic nature of their relationships with health professionals. 9me described being reluctant to ask questions or deliberately withheld information from them.This encouraged distrust and passivity in health care interactions and undermined participants' role as active self-managers of their condition. 9 12 It was concluded that the majority of the interventions were educational with only a small psychosocial component. 12Moreover, ulceration and healing were not reported in most studies and secondary outcomes varied.In groups where participants had prior ulceration, educational interventions had no clear effect on new ulceration (low-quality evidence). 12Notably, the review reaffirmed the findings by Westby et al. 10 that interventions have no clear effect on the prevention of recurrent DFUs.Taken together, these observations suggest that in persons with previous DFUs, low intensity foot self-care behavioural strategies may be insufficient in preventing recurrent DFUs.Similarly, a Cochrane review by McGloin et al. 13 was unable to determine whether psychological interventions are of any benefit to people with an active DFU or a history of DFUs to achieve complete wound healing or prevent recurrence because there is a paucity of trials testing a psychological intervention.Few of the included studies measured all outcomes of interest, and where they did so, the evidence deemed to be of very low certainty.The methodological factors which could explain the findings include the lack of a psychological theory, sample selection bias by HbA 1c , mental health, diabetes complications status, definition of primary and secondary outcomes, and lack of co-production of intervention with patients. 13her process factors that are missing in the literature include assessment of implementation such as fidelity (adherence and com-

| ENHANCING FOOT SELF-CARE THROUGH TECHNOLOGICAL INNOVATIONS
6][17] These advancements have accelerated the integration of effective interventions into the standard clinical protocols for managing DFUs.However, achieving these preventative measures necessitates a shift in the current healthcare paradigm, from one where the patient is a passive recipient of care to one where patients play an active central role in self-managing their health. 15This change in perspective not only introduces challenges but also opportunities for innovation. 17 depicted in Figure 1, a framework for DFU management utilising digital health technology comprises three fundamental elements.First, a sensing unit, which vigilantly monitors DFU-associated risk factors and signs of suboptimal wound healing, with feedback mechanisms.Second, the application of advanced data processing methods such as artificial intelligence (AI).AI is leveraged to transform raw sensory data into actionable insights, enabling personalised risk assessment and intervention strategies.This part of the framework is supported by data-driven learning and discovery, which allows for ongoing refinement and improvement of these AI models.
Finally, a behavioural module can strengthen adherence to the treatment plan and also support daily DFU risk monitoring.This element leverages the insights generated by AI, providing patients with expandable and interpretable information that enhances their understanding and management of their condition.POUWER ET AL.

| Empowering patients in screening for early signs of DFU
4][25][26][27] For these tools to be effective, patients also need to decrease physical activity upon detecting a "hot spot", thereby significantly reducing the risk of ulcer recurrence. 27wever, rigorous studies investigating practical solutions to enforce patient adherence to post-detection management strategies, including the reduction of weight-bearing activities, are currently lacking.

| Empowering patients in managing harmful weight bearing activities
In the realm of DFU prevention, innovative technologies have recently been developed to remotely measure repetitive stress, thereby empowering patients to reduce detrimental plantar tissue stress and potentially prevent DFUs. 28Digital health technologies such as smart insoles have been designed to remotely monitor continuous plantar pressure, providing alert-based feedback to the user when plantar pressures exceed safe limits. 29An alert-based offloading system improved adherence in patients with diabetic foot disease. 29This system used a smartwatch to issue alerts based on plantar surface foot pressure data. 29The alerts guided the participants on offloading activities, such as taking a few steps after prolonged sitting or standing. 29Another prospective, randomised clinical trial of an intelligent pressure-sensing system?demonstrated 71% reduction in DFU recurrence in the intervention as compared to the control group. 30Secondary analyses showed continuous plantar pressure feedback modifies patients' behaviour: they pre-emptively offload high-pressure areas, thereby reducing re-ulceration risk. 30

| Promoting adherence to health-management plans
Patients with an active DFU or a history of DFUs are often recommended to use specialised footwear or casts to alleviate pressure on the affected area of the foot, a process known as offloading.However, the effectiveness of offloading frequently falls short due to suboptimal use of these prescribed devices. 15,161][32][33] However, with the advent of wearable technology, digital health, and remote patient monitoring systems, new solutions are emerging to reinforce adherence to prescribed offloading. 15,28I G U R E 1 This figure illustrates a comprehensive digital health technology framework for DFU management.This includes: a sensing unit to monitor DFU risk factors and signs of poor wound healing; AI-enabled data processing to transform raw data into personalised risk assessments and interventions; and a behavioural module to reinforce treatment adherence and daily risk monitoring, all interconnected through features like measurement-feedback, data-driven learning, and interpretable information.SmartBoot (Sensoria, WA, USA) 33,34 uses an inertial sensor attached to the prescribed offloading device, a smartwatch to engage the patient in wearing the offloading device, and a cloud-based system to enable caregivers and healthcare providers to remotely monitor adherence and other risk factors that might affect the wound healing process.Park et al. 34 validated this technology's capability to measure relevant parameters, and Frinco et al. 33 demonstrated its acceptability, perceived ease of use, perceived benefits, technology-related anxiety, data privacy concerns, and intended use through interviewing a group of patients with DFUs who utilised various offloading types, including SmartBoot.

| DIGITAL TECHNOLOGY-THE PATIENT AND HEALTH CARE PROVIDERS PERSPECTIVES
While promising, digital technologies introduce additional layers of complexity to footcare, with technology design, cost, alignment with patient goals and integration with health-care as previously identified important factors. 35,36It is imperative that end users be consulted in the design process and established theories of technology adoption are used to inform design and implementation. 35,368][39] These studies used the Unified Theory of Acceptance and Use of Technology (UTAUT) as a theoretical underpinning, which articulates the way in which key psychosocial domains interact to influence behavioural intention to adopt a technology in a healthcare context for both patients and health professionals. 40,41Both quantitative UTAUT survey data and focus group thematic analysis found that patients had a positive attitude to technology, with self-efficacy and attitude as key determinants of behavioural intention, and that performance expectancy and effort expectancy were moderating factors. 38For healthcare providers, performance expectancy was the single predictor of behavioural intention to use the technology, with the focus groups identifying that their intention to recommend the technology will be influenced by patient socioeconomic status, culture and footwear preferences. 39Using these findings, a 4-week feasibility study examined a podiatrist-led health coaching intervention to facilitate smart shoe insole adoption by people at high DFU risk. 37Following the health coaching intervention, this study assessed changes over 4 weeks in the actual use of the insole, future behavioural intention to use the smart insole technology, participant understanding of their foot health risk, and self-reported foot care.Results showed excellent use of a smart insole over the 4 weeks, where mean daily insole wear time of over 12 h per day surpassing previous reports. 29,42wever, there was a decline in responses to the alert-based cues from the technology over time, and the UTAUT scores demonstrated significant post trial reductions in attitude and behavioural intention. 39The qualitative findings clarified, at least to some extent, these somewhat incongruous results.It was clear at the end of the 4-week trial that the functionality of the insole technology did not meet original expectations.Frustration was expressed with technology malfunctions and restrictions on the type of footwear that could be worn.Themes emerged of a potential disconnect between a patient's perception of what the technology is measuring and what the technology is actually designed to measure.Patients may not understand why they are receiving alerts when undertaking seemingly innocuous activities such as standing or sitting, and patients reported that alerts were becoming intrusive, particularly during social interactions and daily tasks.In keeping with previous research, 43,44 this may be linked to a patient's history of diabetes-related foot complications.For participants who had not previously experienced DFU, the system appeared of little personal relevance and, the alerts appeared at times random and significantly diminished their level of trust in the device.On the other hand, those with a previous DFU, although they believed the device provided accurate feedback, felt that there was little they could do to permanently mitigate high pressure areas under their feet.Emotional responses also play an important role when considering the usefulness of technology, as described by Andy Lavender: "did the use of the technology reduce stress, did it change how you feel about going out for a walk, did it lessen the stress felt by family members about you going out for a walk and was the mental health aspect of DFU worry reduced".

| DISCUSSION
The present review focused on key barriers that hamper optimal foot self-care.Common patient-reported barriers consist of lack of knowledge, lack of visible symptoms, and the perception that foot self-care has a lower priority than blood glucose management.
Among additional obstacles are the physical and cognitive limitations, frustrations with wearing the prescribed footwear or other orthotic devices and poor communication style of health professionals' (being insensitive, paternalistic, not patient centred).The absence of shared decision-making was identified as a key barrier by persons with diabetic foot complications.Moreover, depression appeared to be a key risk factor for poor future health outcomes.
In a recent perspective article with a broader focus, Pouwer et al described a modified biopsychosocial model of diabetic neuropathy experience. 45In addition to biological factors (DFU, pain, medication side effects, postural instability etc.), and psychological factors (such as self-care behaviours, depression, catastrophic thinking, fears etc.) social factors were also included, including racism, health care affordability and social/physical environment. 45,46 the area of DFU, interventions that address psychological barriers are scarce; therefore, new studies are urgently needed.
Intervention studies should be developed, where patient-reported barriers are assessed in an early stage, and then targeted by means of stepped, personalised care.The new guidelines advise using a clinical question to address whether psychological interventions should be offered or provided, but give no guidance how to do this. 1 The use of a well-validated questionnaire might be preferable.Such a screening/monitoring tool could focus on unmet care needs and POUWER ET AL. treatment barriers such as knowledge gaps, low treatment satisfaction and poor emotional health.Using automated web-based or appbased assessments can save time as patients can answer the questions at home or in the waiting room.Health care providers can receive a summary regarding patient-reported unmet care needs that should be discussed.Future guidelines should provide guidance on discussing screening results, and also, how to treat the identified problems in an evidence-based and cost-effective way.For example, in case of depressed mood, a web-based psychological intervention could be offered in the first stage and in case of more severe problems, a social worker or a mental health care specialist (medical psychologist or psychiatrist) could be consulted. 47,48e importance of social determinants of health (SDOH) in developing diabetic foot problems is underresearched.A review investigating the relationship between DFU and the SDOH factors such as socioeconomic status, racism and geographical remoteness has produced conflicting results. 46nally, the adoption of digital technology in people with or at risk of diabetes foot complications is likely influenced by a complex

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POUWER ET AL.FACTORS AND INTERVENTIONS IN DFU PREVENTION Recently conducted systematic reviews have examined the role of psychological and behavioural factors in the development and healing of DFUs, and the effects of psychological interventions on DFU healing and recurrence.For example, a review of the prognostic psychological and behavioural factors in DFU development and healing identified 15 eligible studies involving over 12.000 participants. 10The authors found significantly different results for people with and without prior DFU.Specifically, for persons with no prior DFU, moderate quality evidence suggests that depression increases DFU risk [three studies, for example, HR 1.68 (1.20, 2.35) per Hospital Anxiety and Depression Scale standard unit, whereas better foot self-care behaviour reduces DFU risk [HR 0.61 (0.40, 0.93)] per Summary of Diabetes Self-Care Activities scale standard unit. 10,11For people with diabetes and previous DFUs, low-or very low-quality evidence suggests no significant association between DFU recurrence and depression, foot self-care, footwear adherence or exercise.The authors therefore concluded that psychosocial and behavioural factors may influence the development of first DFUs, while more high-quality research is needed on DFU recurrence and healing. 10Other systematic reviews aimed to identify and synthesise the evidence for the effectiveness of psychosocial interventions to promote the healing or reduce the occurrence of DFUs.Norman et al. have summarised the results of trials that have investigated the effectiveness of psychosocial interventions for the prevention and treatment of DFUs in people with diabetes.
petency); context (for instance low intensity psychological treatments are cheaper and therefore funding more likely); studying the mechanism of action such as attempting to identify which Cognitive Behavioural Techniques are most potent and which psychological processes, such as denial or fear, are being targeted.Importantly, no adequate consideration was given to the mechanisms by which these interventions were expected to result in fewer DFUs, except for some generic propositions that emerged from stress and wound healing research, suggesting that such interventions may work through promoting healthy behaviours (e.g.adequate sleep, physical activity, healthy nutrition) and improving social interaction.Foot selfcare actions that are specific to DFU prevention and healing were addressed insufficiently or not addressed at all, thereby failing to provide evidence for the role of foot self-care in DFU prevention or healing.The most recent overview of systematic reviews in DFU prevention, 14 revealed how substantial is the overlapping nature of the evidence from systematic reviews addressing DFU prevention and crucially, the same (largely poor-quality) trials being reviewed repeatedly without our understanding about what works to improve patient outcomes becoming any clearer.
set of interacting factors.Adults with diabetes are open to trying the emerging foot monitoring technologies and, if given appropriate support, they are likely to successfully use such devices.To support digital technology implementation, it should measure variables with evidence of predictive value in prevention, while the use of technology should be accompanied by a planned communication strategy that is personalised to the patient and focuses on education, goal setting and self-management skills within the context of sociocultural factors.