Factors influencing the use of therapeutic footwear in persons with diabetes mellitus and loss of protective sensation: A focus group study.

BACKGROUND: Persons with diabetes mellitus (DM) and loss of protective sensation (LOPS) due to peripheral neuropathy do not use their therapeutic footwear (TF) consistently. TF is essential to prevent foot ulceration. In order to improve compliance in using TF, influencing factors need to be identified and analyzed. Persons with a history of foot ulceration may find different factors important compared with persons without ulceration or persons who have never used TF. Therefore, the objective of this study was to determine factors perceived as important for the use of TF by different groups of persons with DM and LOPS. METHOD: A qualitative study was performed using focus group discussions. Subjects (n = 24) were divided into 3 focus groups based on disease severity: ulcer history (HoU) versus no ulcer history (no-HoU) and experience with TF (TF) versus no experience (no-TF). For each group of 8 subjects (TF&HoU; TF&no-HoU; no-TF&no-HoU), an online focus group discussion was organized to identify the most important influencing factors. Transcribed data were coded with Atlas.ti. The analysis was performed following the framework approach. RESULTS: The factors comfort and fit and stability/balance were ranked in the top 3 of all groups. Usability was ranked in the top 3 of group-TF&noHoU and group-noTF&noHoU. Two other factors, reducing pain and preventing ulceration were ranked in the top 3 of group-TF&noHoU and group-TF&HoU, respectively. CONCLUSION: Experience with TF and a HoU influence which factors are perceived as important for TF use. Knowledge of these factors during the development and prescription process of TF may lead to increased compliance. Although the main medical reason for TF prescription is ulcer prevention, only 1 group gave this factor a high ranking. Therefore, next to focusing on influencing factors, person-centered education on the importance of using TF to prevent ulcers is also required.

A population-based cohort of adult patients with diabetes mellitus in a Western District of Austria: The Diabetes Landeck cohort.

INTRODUCTION: Diabetes mellitus (DM) has become an important and exacerbating health epidemic, with severe consequences for both patients and health systems. The National Diabetes Strategy of Austria addresses the lack of high-quality data on DM in Austria and the need for developing a national data network. The aims of our study are to establish a cohort including all adult diabetes patients in a district in western Austria, describe the demographic and clinical characteristics of this cohort, and provide an estimation of diabetes prevalence. METHODS: We recruited a population-based cohort of adult patients with a diagnosis of DM in cooperation with a network of all caregivers. Data collection was based on a case report form, including patient characteristics, clinical parameters and long-term complications. RESULTS: In total, 1845 patients with DM were recruited and analysed. We observed an overall prevalence of 5.3% [95% CI: 5.0%-5.5%]. For the subsequent main analysis, we included 1755 patients with DM after excluding 90 patients with gestational DM. There were significant differences between genders in the distribution of specific clinical parameters, patient characteristics, and the long-term complications diabetic foot, amputation and cardiovascular disease. CONCLUSION: To the best of our knowledge, we established the first diabetes cohort study in Austria. Prevalence and the proportion of specific long-term complications were lower when compared to the international context. We assume that the Diabetes Landeck Cohort has reached a high degree of completeness; however, we were not able to identify independent data sources for a valid check of completeness.

Evidence of greater severity of diabetic foot ulcers during COVID-19 pandemic: A real-life single-centre cohort study.

AIMS: In the Sars-Cov-2 pandemic era, patients with diabetes mellitus (DM) manifested more severe forms of Sars-Cov-2 with greater mortality than non-diabetic patients. Several studies documented more aggressive forms of diabetic foot ulcers (DFU) during the pandemic period even though the results were not unanimously confirmed. The aim of this study was to evaluate the clinical-demographic differences between a cohort of Sicilian diabetic patients hospitalised for DFU in the pre-pandemic 3 years and a cohort of patients hospitalised in the pandemic 2 years. MATERIALS AND METHODS: One hundred and eleven patients from the pre-pandemic period 2017-2019 (Group A) and 86 patients from the pandemic period 2020-2021 (Group B) with DFU, admitted to the division of Endocrinology and Metabolism of the University Hospital of Palermo, were retrospectively evaluated. The clinical assessment of the type, staging and grading of the lesion, and the infective complication from DFU was performed. RESULTS: No differences in HbA1c values were observed between the two groups. Group B showed a significantly higher prevalence of male subjects (p = 0.010), neuro-ischaemic ulcers (p < 0.001), deep ulcers with involvement of bones (p < 0.001), white blood count levels (p < 0.001), and reactive C protein (p = 0.001) compared to group A. CONCLUSIONS: Our data show that in the COVID-19 pandemic, a greater severity of ulcers requiring a significantly greater number of revascularisations and more expensive therapy, but without an increase in the amputation rate, was observed. These data provide novel information on the impact of the pandemic on diabetic foot ulcer risk and progression.

Relax to Heal? Perspectives of Patients with Diabetic Foot Ulcers and Health Professionals on Relaxation Sessions for Wound Healing.

OBJECTIVE: To explore patients' and healthcare professionals' (HPs') perspectives on the suitability/acceptability of a relaxation intervention, its effects on patients' well-being and diabetic foot ulcer (DFU) healing, and its incorporation into the multidisciplinary management of patients with diabetic foot. METHODS: This qualitative study was nested within a three-arm pilot randomized controlled trial. Patients with a chronic DFU received four relaxation sessions. Investigators then interviewed patients, physicians, and nurses involved with diabetic foot consultations. Interviews were audio-recorded, transcribed, and analyzed using thematic content analysis. RESULTS: Five themes emerged from patient's interviews about the suitability/acceptability of the relaxation intervention: perceptions regarding the psychological intervention, distress, the relaxation technique, changes in the patient's life, and changes in DFU/contribution to healing. Three themes emerged from interviews with HPs: perceptions regarding relaxation, changes in the patient, and changes in DFU/healing. Regarding the feasibility of the relaxation intervention, three themes emerged for both patients and HPs: suggested modifications, stressors/difficulties, and impact of COVID-19 pandemic. The utility theme emerged only in HP interviews, with subthemes of patients' distress, psychological interventions, relaxation intervention, and integration of the psychologist in the team. CONCLUSIONS: These findings provide evidence for the suitability/acceptability, feasibility, and utility of a relaxation intervention in diabetic foot consultations.

A review of disparities in peripheral artery disease and diabetes-related amputations during the COVID-19 pandemic.

The COVID-19 pandemic has profoundly affected health care delivery. In addition to the significant morbidity and mortality associated with acute illness from COVID-19, the indirect impact has been far-reaching, including substantial disruptions in chronic disease care. As a result of pandemic disruptions in health care, vulnerable and minority populations have faced health inequalities. The aim of this review was to investigate how the COVID-19 pandemic has impacted vulnerable populations with limb-threatening peripheral artery disease and diabetic foot infections.

User involvement throughout development of technology to support diabetes foot care: a case illustration of the devices for dignity PPIE model.

The successful development and implementation of any healthcare technology requires input from multiple stakeholders including clinical leads, trust information technology directorates as well as project management and procurement. In this process however, a key stakeholder that is often overlooked is the patient.This paper illustrates the crucial importance of patient involvement to avoid poor design and poor uptake of technology and subsequently poor health outcomes.To highlight this, we share a case example evidencing involvement of people with lived experience of foot ulcers resulting from Diabetic foot neuropathy throughout identification of unmet technology needs, design requirements for the device and iterative device development and evaluation.

The war in Ukraine and diabetic foot care: Challenges, recommendations.

AIMS: A number of reports have illustrated the barriers that the war in Ukraine puts to diabetes care. While their recommendations are valuable for glycemic control and the prevention or early detection of life - threatening diabetes complications, such as hypoglycemia and ketoacidosis, the discourse on diabetic foot is limited. This letter emphasizes the implications of the war in diabetic foot care and discusses potential solutions. METHODS: The authors searched peer - reviewed and grey literature to identify records related to the prevalence of diabetic foot in Ukraine and the standards of care before and after the invasion of Ukraine. RESULTS: Thousands of people in Ukraine sustain diabetic foot ulcers and, thus, are at high risk for lower limb amputations due to the limited access to healthcare services in the country. If not addressed, disability associated with chronic ulcers and amputations can severely affect individual and public health in Ukraine. Strengthening primary and remote care, educating people on self - care and providing adequate supplies for the management of diabetic foot have a major potential to prevent amputations, disability and death. CONCLUSIONS: Providing adequate diabetic foot care in Ukraine and other regions tormented by armed conflicts is vital for the health of the local population and the potential of the affected countries to recover after the crisis.

Severe diabetic foot infections without systemic inflammatory response syndrome: Prospective validation of a new category.

We aimed to validate the prognostic value of subclassifying moderate diabetic foot infections into two categories: moderate and moderate/severe. We conducted a prospective study of a cohort of 200 patients with moderate and severe infections. Moderate infections were subclassified after applying a previously published score. Variables associated with prognosis were: need for any amputation, major amputation, need for hospitalisation, length of hospitalisation, length of antibiotic therapy, reinfection rate and infection-related mortality. Infections were moderate in 111 cases (55.5%) and severe in 89 (44.5%). Osteomyelitis (OM) was diagnosed in 114 cases (57%), 73 moderate (36.5%) and 41 severe (20.5%). Patients with severe OM had a higher rate of amputations, major amputations, hospitalisations and need for antibiotic therapy, and a longer duration of antibiotics when compared with moderate OM. After applying the score, moderate infections were subclassified into 73 moderate cases (65.7%) and 38 moderate/severe cases (34.3%). Moderate/severe had a higher rate of amputations, major amputations, hospitalisations and need for antibiotics than moderate ones. No differences regarding prognosis were found between moderate/severe and severe infections with systemic inflammatory response syndrome. Moderate/severe diabetic foot infections, which could also be known as severe infections without systemic inflammatory response syndrome, should be recognised as a new subgroup. We propose to merge severe diabetic foot infections with and without systemic inflammatory response syndrome into a unique category due to its prognostic value. Furthermore, OM should be added to both moderate and severe new categories of diabetic foot infections.

Research priorities to prevent and treat diabetic foot ulcers-A digital James Lind Alliance Priority Setting Partnership.

AIM: To establish outcomes of a priority setting partnership between participants with diabetes mellitus and clinicians to identify the top 10 research priorities for preventing and treating diabetic foot ulcers (DFUs). METHODS: Due to the COVID-19 pandemic, the James Lind Alliance Priority Setting Partnership process was adapted into a digital format which involved a pilot survey to identify understandable uncertainties with high relevance for participants tested by calculating the content validity index; a main survey answered by 53 participants living with diabetes and 49 clinicians; and a final digital workshop to process and prioritise the final top 10 research priorities. RESULTS: The content validity index was satisfactory for 20 out of 25 uncertainties followed by minor changes and one additional uncertainty. After we processed the 26 uncertainties from the main survey and seven current guidelines, a list of 28 research uncertainties remained for review and discussion in the digital workshop. The final top 10 research priorities included the organisation of diabetes care; screening of diabetes, impaired blood circulation, neuropathy, and skin properties; vascular surgical treatment; importance of self-care; help from significant others; pressure relief; and prevention of infection. CONCLUSION: The top 10 research priorities for preventing and treating DFUs represent consensus areas from persons living with diabetes and clinicians to guide future research. These research priorities can justify and inform strategic allocation of research funding. The digitalisation of James Lind Alliance methodology was feasible.

Treatment of diabetic foot during the COVID-19 pandemic: A systematic review.

BACKGROUND: In the context of the novel coronavirus disease 2019 (COVID-19) pandemic, people have had to stay at home more and make fewer trips to the hospital. Furthermore, hospitals give priority to the treatment of COVID-19 patients. These factors are not conducive to the treatment of diabetic foot, and even increase the risk of amputation. Therefore, how to better treat patients with diabetic foot during the COVID-19 epidemic, prevent further aggravation of the disease and reduce the risk of amputation in patients with diabetic foot has become an urgent problem for doctors around the world. METHODS: The researchers searched PubMed, the Cochrane Library, and the Embase database. The retrieval time was set from the database establishment to October 2021. All studies on treatment of diabetic foot in the COVID-19 pandemic were included in our study. RESULTS: A total of 6 studies were included in this study. In the 6 protocols for treating patients with diabetic foot, the researchers classified patients according to the condition of their diabetic foot. Diabetic foot patients with general conditions received treatment at home, and doctors can guide the wound dressing change and medication treatment of patients through telemedicine. Patients with severe conditions of diabetic foot were admitted to hospital for treatment. Patients were screened for COVID-19 before hospitalization, those infected or suspected of COVID-19 were treated in isolation, and those not infected with COVID-19 were treated in a general ward. CONCLUSION: Through this systematic review, we proposed a new protocol for the treatment of patients with diabetic foot in the context of the COVID-19 pandemic. It provided reference for the treatment of diabetic foot in the context of COVID-19 epidemic. However, the global applicability of the treatment protocol for diabetic foot in the context of COVID-19 epidemic proposed in this study needs further clinical testing.

Holistic care of patients with diabetic foot ulcers during the COVID-19 era: integration of Henderson's Need Theory.

The COVID-19 pandemic has inhibited the practice of diabetic foot ulcer care, particularly in the community. Comprehensive theory-based nursing care is needed to prevent further complications. Unfortunately, a study combining theory with nursing care in diabetic foot ulcer care has not been explored. When caring for patients with diabetic foot ulcers, who are also at increased risk of severe complications from COVID-19, it is important to take a holistic view of the patient and consider all of their needs and the factors affecting them. Henderson's Need Theory and the 14 basic needs contained within it was chosen to be integrated in the care of patients with diabetic foot ulcers during the pandemic, with the hope that the findings will help nurses to optimise care in both hospital-based and community practice.

Effects of the COVID-19 pandemic on the management of diabetic foot ulcers: experiences from a dedicated diabetic foot care center.

INTRODUCTION: As did many other nations, the Turkish government implemented precautions and lockdown measures in response to the rapid spread of the COVID-19 viral infection. The pandemic has caused millions of deaths globally, resulted in the development of comorbidities, and negatively affected national health care systems. The increased workload at hospitals and spread of the virus among health care professionals have resulted in delays in health care services delivery. The fear of COVID-19 transmission has resulted in people mostly staying at home. OBJECTIVE: The aim of this study is to present the effects of the pandemic on the behavior of patients with diabetic foot ulcers (DFUs). MATERIALS AND METHODS: Patients with DFU were categorized into 2 groups: patients hospitalized during the COVID-19 pandemic and patients hospitalized during the same period in 2019 (prepandemic). Demographic data, length of hospital stay, place of residence, Wagner grade of DFU, comorbidities, laboratory parameters, wound duration, duration of diabetes, and treatments applied were recorded. RESULTS: During the pandemic, the length of hospital stay decreased, and patient referrals from other cities significantly decreased (P <.001). Hemoglobin A1c level was higher and Wagner grade was more advanced during the pandemic period (P =.014 and P =.033, respectively). The number of patients undergoing debridement alone decreased during the pandemic period, while those requiring amputation increased (P =.008 and P =.005, respectively). CONCLUSIONS: Patients with DFU delayed seeking timely proper medical advice during the pandemic. This resulted in a significantly higher amputation rate, with physical, psychosocial, and economic consequences. Virtual techniques (eg, video consultation) can be used to identify patients who require hospitalization. Close follow-up can be provided via home nursing care and by supplying advanced wound care products for in-home use. Patients with DFU should be encouraged to seek proper medical advice and take recommended precautions.

Hospitalisation rate and mortality among people with and without diabetes during the COVID-19 pandemic year 2020.

Most studies reported reduced health care use among people with diabetes during the COVID-19 pandemic. This may be due to restricted medical services or people avoiding health care services because they fear being infected with COVID-19 in health care facilities. The aim of our study was to analyse hospitalisation and mortality in people with and without diabetes in Germany during the COVID-19 pandemic year 2020 compared to 2017-2019. The data were sourced from a German statutory health insurance company covering 3.2 million people. We estimated age-sex standardised rates of mortality, all-cause hospitalisation, hospitalisation due to coronary heart disease (CHD), acute myocardial infarction (AMI), stroke, diabetic foot syndrome (DFS), and major and minor amputations in people with and without diabetes. We predicted rates for 2020 using Poisson regression based on results from 2017-2019 and compared these with the observed rates.In people with diabetes, the hospitalisation rate for major amputation was significantly increased, while all-cause hospitalisation rate and hospitalisation due to CHD, AMI and DFS were significantly decreased compared to the previous period. Moreover, we found a significantly increased mortality and hospitalisation rate for minor amputation in people without diabetes while all-cause hospitalisation and hospitalisation due to CHD and AMI was significantly lower during the COVID-19 pandemic year 2020.We observed changes in health care utilisation and outcomes during the COVID-19 pandemic compared to previous years in people with and without diabetes. Concerning diabetes care, the increase of hospitalisations due to amputation in people with diabetes with a simultaneous reduction in DFS needs special attention.

A multicenter clinical trial evaluating the durability of diabetic foot ulcer healing in ulcers treated with topical oxygen and standard of care versus standard of care alone 1 year post healing.

Multiple clinical trials and real-world studies have demonstrated accelerated healing in diabetic foot ulcers (DFU) treated with advanced modalities, such as topical oxygen therapy (TOT). In addition to healing, the durability of wound closure is a crucial long-term endpoint for DFU clinical trials: an advanced treatment that does not confer a reasonable ulcer-free period will have limited clinical benefit and modest economic value. Preclinical studies suggest that DFUs receiving topical oxygen therapy will experience improved quality of healing: increased collagen deposition and angiogenesis. It is postulated that these changes will translate into a more long-lasting closure for ulcers treated with TOT and SOC compared to ulcers treated with SOC alone. At the conclusion of a recently completed randomised controlled DFU clinical trial evaluating the efficacy of TOT and SOC compared to SOC alone, patients with healed ulcers were asked to enrol in a long-term follow-up study. Healed patients completed four questionnaires through text messages or phone calls within 1-year post completion of the trial. Twenty-nine patients consented to participate in the long-term follow-up trial (17 TOT/SOC and 12 SOC). Only seven subjects were lost to follow up (5 TOT and 2 SOC). This is a surprisingly low number when factoring in the disruption caused by the COVID-19 pandemic that continued throughout the entire follow-up period. In the remaining patients, 85% of the TOT patients and 60% of the SOC remained healed at 1 year. There was one major amputation, which occurred in an SOC-treated patient. The numbers in the long-term follow-up were too small to reach statistical significance; however, there is a strong trend toward more durable closure in ulcers treated with TOT.

Characteristics of Diabetic Foot Ulcer Patients Pre- and During COVID-19 Pandemic: Lessons Learnt From a National Referral Hospital in Indonesia.

BACKGROUND: Diabetic foot ulcer (DFU) is one of the most terrifying diabetic complications for patients, due to the high mortality rate and risk for amputation. During the COVID-19 pandemic, many diabetic patients limited their visits to the hospital, resulting in delays for treatment especially in emergency cases. OBJECTIVE: This study aimed to compare the characteristics of patients with DFU pre- and during COVID-19 pandemic period. Methods: This study was a retrospective cohort study using foot registry data. We compared our patients' characteristics pre-COVID-19 pandemic period (1 March 2019-28 February 2020) and during COVID-19 pandemic period (1 March 2020-28 February 2021). RESULTS: Cohorts of 84 and 71 patients with DFU pre- and during COVID-19 pandemic period, respectively, were included in this study. High infection grade (66.7% vs 83.1%, P = .032), osteomyelitis event (72.6% vs 87.3%, P = .04), leukocyte count (15 565.0/µL vs 20 280.0/µL, P = .002), neutrophil-to-lymphocyte ratio (7.7 vs 12.1, P = .008), waiting time-to-surgery (39.0 h vs 78.5 h, P = .034), and number of major amputation (20.2% vs 39.4%, P = .014) were significantly higher during the COVID-19 pandemic period. CONCLUSION: During the COVID-19 pandemic, patients with DFU had more severe infection, higher proportion of osteomyelitis, longer waiting time for getting surgical intervention, and higher incidence of major amputation.

Telemedicine and diabetic foot ulcer outcomes. A meta-analysis of controlled trials.

Telemedicine (TM) has been advanced as an effective approach to wound care management. In this era of COVID-19 pandemic, it is paramount to assess the evidence behind the use of TM in treating diabetic foot ulcers (DFU). This meta-analysis aims at evaluating the efficacy of TM versus face-to-face attendance in managing DFU. In total, four controlled studies were included in the meta-analysis comprising 3 randomized trials. The total pooled sample comprised 816 patients (816 ulcers): 337 in TM group and 479 in the control group. The results were as follows: (a) healing rate OR was 1.35, in favor of TM (p = 0.4), (b) time to heal with means of 73 ± 24.1 days and 83.5 ± 28.4 days, for the TM and control group, respectively (p = 0.35), c) the amputation rate OR was 0.48 (p = 0.007) in favor of the TM group, d) the mortality rate OR was 1.66 (p = 0.2), and e) a trend for lesser cost than face-to-face group (p = 0.4). While future research using large-sampled controlled studies is warranted, the present meta-analysis demonstrated that treating DFU via TM could be at least as effective as to face-to-face attendance. In times where clinic visits are reduced or not possible such as during this COVID-19 pandemic and the likely-to-happen future outbreaks, TM could be a valuable alternative.

Diabetic Foot Syndrome in the COVID-19 era: How to Move from Classical to new Approaches.

Diabetic foot syndrome (DFS) is a major complication of diabetes mellitus. Coronavirus infectious disease 2019 (COVID-19) has created new necessities and priorities in DFS management. These include telemedicine and patient triage to minimise hospitalisation and visits to the clinic. Moreover, new studies will be needed to evaluate whether the lockdown in patients with DFS or in those with high risk of DFS have increased the risk of deteriorating outcomes, including limb loss. Our future challenge will lie in re-organising our world during the pandemic and after its resolution. We need more awareness of the widespread ways of the changes in taking care of patients and to improve education, skills, and behaviour of high-risk patients.

Health economics of diabetic foot ulcer and recent trends to accelerate treatment.

Diabetic foot ulcer is a preventable complication of diabetes that imposes a significant burden on the community. It leads to amputation and increased disability if left untreated and thus bears profound implications on the individual, the community and the health system at large. Diabetic foot (DF) is an area of research interest where interdisciplinary researchers are trying to elucidate the best strategy to halt the progression of chronic diabetic wounds. It is an area where tissue engineering research is making a strong impact through the use of scaffolds and skin substitutes for diabetic wound healing. This review aims at discussing the geographical health economics, its impact on healing and factors influencing financial costs of DFU. The upcoming economic and clinical impacts due to disease outbreak such as the 2020 COVID-19 has also been discussed. Finally, it will discuss novel therapy available with emphasis on skin tissue engineering scaffolds with a cost-benefit analysis. The review aims at promoting better management of people with diabetes with emphasis on emerging treatments and technologies.