The integration of new technologies can call for obeying different rules and should be considered a long-term evolutionary process that is realised step by step. Before a medical device appears in the market, a long regulatory process has been completed, including safety, experimental and preclinical studies leading to an authorisation for distribution in a national market. Depending on the target countries and their respective regulations, the need for robust clinical studies, including randomised clinical trials, is often mandatory for distribution. Post-clinical trials may be used to confirm the results obtained from a medical device. The efficacy of the introduction of new technology in daily practice is then dependent on clinicians’ perceptions of the improvement in wound-healing. Complications may occur even after a long period of time, with severe consequences for patients’ quality of life. Since the PIP (Poly Implant Prothèse) scandal, more restrictions have been imposed to prevent such failures and increase the safety for the population.

Background Existing evidence suggests that adherence to treatment plans and long-term lifestyle modifications could reduce costly complications associated with diabetes, such as diabetic foot ulcers (DFU). Applying biopsychosocial models and theories to practice can help clinicians understand why individuals adopt or reject certain health behaviours.

Aims This review explores the dynamic between patients’ psychosocial behaviours and their levels of commitment to treatment plans, discusses approaches for improving the therapeutic relationship between health care professionals (HCPs) and patients through collaborative healthcare planning and raises awareness of the importance of identifying the psychological barriers to managing outcomes of chronic illnesses.

Methods This is a narrative exploration of health belief theories applied to managing diabetes and DFU, including a discussion of ‘compliance’, ‘adherence’ and ‘concordance’; health psychology theories on adherence behaviours; and the role of emotional responses in influencing the acceptance of long-term treatments.

Findings Evidence highlighted the role of psychosocial factors in influencing a person’s decision-making process and noted individual differences in the willingness to conform to certain health and treatment recommendations, based on prior assumptions and know-ledge extending beyond a longer-term conception of the benefits and risks of behaviours or disease progression.

Conclusions Healthcare planning should shift from labelling patients as ‘non-compliant’ toward promoting collaborative conversations that inform choices and actions. HCPs should acknowledge the importance of patients’ knowledge and views about their health and create treatment plans that best suit these individual needs. Future research should develop health belief models to incorporate patients’ emotional responses to chronic illness.

Key messages

Compliance and adherence, when used to describe patients’ health behaviours, allude to both the expectations and judgments of expert medical professionals, but differ in terms of the perceived level of input from patients.

Adequate knowledge and understanding of a disease is widely assumed to help maintain an acceptable level of adherence to a treatment plan or an overall healthy lifestyle; however, the field of behavioural research has conceded that ‘knowing’ does not necessarily transform into ‘doing’.

To foster a successful healthcare provider–patient relationship, patients’ own knowledge and health beliefs must be acknowledged and included in discussions related to treatment plans, so as to improve adherence to treatment.

Gaining concordance with the patient is the most important tool in a health care professional’s arsenal; this refers to working in collaboration with patients to agree to their own health care plan.

Background The annual incidence of diabetic foot ulcers (DFU) is estimated to be 2–5% of the diabetic population, and it is estimated that 15% of diabetic patients will develop a DFU during their lifetime.¹ The main contributing factors in the development of DFU are peripheral neuropathy and peripheral vascular disease.² DFUs constitute a significant burden on the patient, their family, and society and pose an important challenge in the treatment of patients with diabetes.³ Roughly 5–8% of patients with a DFU will require a major amputation within one year of the diagnosis, despite aggressive treatment.¹ The WIFI classification, developed by the Society for Vascular Surgery, categorises the risk of major amputation according to the interaction among a wound’s severity (W), degree of foot ischemia (I) and degree of infection (If).⁴ In this study, we examined the effect of negative pressure wound therapy (NPWT) on the outcome of patients with DFU categorised as W2 and W3 according to the WIFI classification. The treatment of wounds and ulcers by the application of negative pressure was developed in the 1990s. The name “Negative Pressure Wound Therapy” was commonly used to describe this technique⁵ It aims to improve a patient’s quality of life by improving healing rates and reducing the healing time of DFUs.⁶ While the effect of NPWT on wound-healing has been investigated in many previous studies,^7–12 its effect on DFUs categorised as ‘severe’ has not been described before.

Aim of the study This study aimed to compare the results after using NPWT to standard wound care in severe DFUs, classified in the WIFI classification system as W2 and W3.

Background Ventilating the critically ill patient with acute respiratory distress syndrome in the prone position is a lifesaving strategy, but it is coupled with adverse consequences such as the development of pressure ulcers.

Aim To develop evidence-based recommendations for critical care clinicians in a concise, simple and visual practice guidance document.

Methods A gap analysis study conducted by the Skin Integrity Research Group and the Swedish Centre for Skin and Wound Research (currently submitted to a peer-reviewed international journal) formed the basis for the practice guidance document. The gap analysis study reviewed which guidelines, equipment/devices and other digital resources were available during a systemic, comprehensive literature and digital search conducted between August and November 2020. An international expert panel reviewed the identified gaps and provided their feedback. The information from the comprehensive search provided the foundation for the design of the practice guidance document.

Findings The “PRONEtect (Prone & Protect) practice guidance document – skin care considerations for the patient in the prone position” was developed by the research team, reviewed and approved by the expert panel and then launched on public platforms in December 2020.

Conclusions The PRONEtect document’s recommendations could assist clinicians in reviewing key considerations for tissue damage prevention in patients in the prone position.

Implications for clinical practice To date, the document has been translated into eight languages, and some critical care units have updated their prone protocols according data presented in this document. This will be a dynamic document and revised as more evidence-based practices and technologies become available, specifically for prone ventilation and the prevention of tissue damage.

Background The literature indicates the impact of psychological factors on the development and course of diabetes remains unclear.

Aim To explore personality, depression, diabetes-related distress and illness beliefs in adults attending routine diabetes clinics and investigate whether the extent of these difficulties can predict foot self-care.

Methods Participants were consecutive patients with diabetes attending diabetes outpatient and podiatry clinics in hospitals who completed self-administered questionnaires to access personality traits and evaluate them for personality disorders, depression, diabetes-related distress, beliefs about illness and foot self-care.

Results Approximately 1 in 5 participants screened positive for Type D personality, personality disorders and diabetic-related distress; 8% screened positive for major depression. A standard multiple regression model determined whether foot self-care was predicted by these variables. The results were non-significant, F (13, 106) = 1.63, p = .09. Having macrovascular complications was significantly positively related to foot self-care (r(118) = .20, p = .027). Participants with a current and/or past history of DFU had higher BMI, longer duration of diabetes, were more likely to be on insulin therapy and to have concomitant microvascular complications.

Conclusion Personality and mood disorders are prevalent in people attending diabetes clinics, but the variables measured here do not predict foot self-care.

Implications for clinical practice Adults attending specialist podiatry/diabetes clinics need clinical pathways to mental health support.

Aims To evaluate the safety and effectiveness of photobiomodulation¹ therapy in addition to the standard of care (SoC) for managing diabetic foot ulceration (DFU), we designed a prospective randomised double-blind trial for neuro-ischemic patients (HERMES study), whose design and study protocol we describe in this paper.

Patients and methods All patients with a chronic neuro-ischemic DFU wider than 1 cm² attending the S. Donato Hospital DF Clinic in Arezzo, Italy (I), will be screened for enrolment.

After two weeks, while patients are treated with SoC, those whose lesions have not decreased by 50% or more in size will be randomised into two groups: the control group will be managed with SoC, while the study group will be treated with photobiomodulation + SoC twice weekly for 20 weeks, or until healing. Both groups will be managed in the community by visiting nurses. The outcomes [healing rates at 24 weeks (primary endpoint), healing times, speed of area reduction, pain, quality of life, adverse events] will be blinded to the treatment.

Results As a pilot study, we cannot anticipate results, but we expect a positive difference of at least 15% in the study group’s primary outcomes, compared to controls, with no worsened safety profile.

Conclusions and implications for clinical practice The interest of the HERMES study, beyond the findings related to the efficacy and safety of photobiomodulation, lies in the characteristics of this low-cost, no-waste technology and its integration in specialist and community-based care.

Background The complications of diabetes mellitus (DM) in the lower limbs, generically known as ‘diabetic foot’ (DF), affect one in three patients with DM at least once in their life and represent the most prevalent cause of lower extremity amputation (LEA) in the world, such that it is estimated that a limb is lost every 20 seconds because of DF.^1,2

Background Optimising wellbeing for those living with DFU is a critical component of holistic patient management. Evidence demonstrates that outcomes improve when patients are actively involved in their care. Yet, wellbeing is often overlooked for patients with DFU and there is a lack of measurement tools regarding this concept.

Aim The aim of this research process was to identify—through PPI collaboration and engagement with patients—the potential for development of a wellbeing tool specifically for people living with DFU.

Methods A PPI panel consisting of six members was established. The COM-B model as a framework and trigger questions on wellbeing were used as a focus for tool generation. The guidance for Reporting Involvement of Patients and the Public 2 – Short Form (GRIPP2-SF) was used to guide the process.

Findings All content was analysed using thematic analysis to map emerging themes and subthemes and create recommendations. A total of five recommendations were developed: 1. Patient education, 2. Self-efficacy, 3. Health literacy and knowledge translation, 4. Social support and 5. Holistic approach.

Conclusions Further research in this area should comprehensively address the holistic elements of wellbeing to optimise outcomes for those with DFU. The development of an outcome tool for wellbeing is required to support further research.

Implications for clinical practice Healthcare professionals should adopt a holistic approach to the care of patients with DFU. Early and positive education strategies are needed, particularly at the point of diagnosis. The participants recommended access to suitable coping strategies and encouragement from care providers to improve self-efficacy. Psychological support should be integrated into the care of people suffering from diabetes and DFU.

Injury to the skin can often lead to wounds that are considered recalcitrant or difficult to heal. Wound care is central to nursing practice. To address the growing demand and exorbitantly high cost of wound management, there is a need to shift from a mechanistic, diseased-oriented perspective to a more humanistic practice paradigm that views patients as active partners.