Effect of Ozone Therapy on Diabetes-related Foot Ulcer Outcomes: A Systematic Review and Meta-analysis.

PURPOSE: This study aimed to assess the effectiveness of ozone therapy in treating Diabetes-related Foot Ulcer (DFU) and its outcomes. METHODS: A systematic search was conducted in PubMed/MEDLINE, Scopus, Web of Science, and ProQuest databases for published studies evaluating the use of ozone as an adjunct treatment for DFU, from inception to December 21, 2022. The primary outcome measure was the change in wound size after the intervention compared to pretreatment. Secondary outcomes included time to complete ulcer healing, number of healed patients, adverse events, amputation rates, and hospital length of stay. Quantitative data synthesis for the meta-analysis was performed using a random-effects model and generic inverse variance method, while overall heterogeneity analysis was conducted using a fixed-effects model. Interstudy heterogeneity was assessed using the I2 index (<50%) and the Cochrane Q statistic test. Sensitivity analysis was performed using the leave-one-out method. RESULTS: The meta-analysis included 11 studies comprising 960 patients with DFU. The results demonstrated a significant positive effect of ozone therapy on reducing foot ulcer size (Standardized Mean Difference (SMD): -25.84, 95% CI: -51.65 to -0.04, p = 0.05), shortening mean healing time (SMD: -38.59, 95% CI: -51.81 to -25.37, p < 0.001), decreasing hospital length of stay (SMD: -8.75, 95% CI: -14.81 to -2.69, p < 0.001), and reducing amputation rates (Relative Risk (RR): 0.46, 95% CI: 0.30-0.71, p < 0.001), compared to standard treatment. CONCLUSION: This meta-analysis indicates that ozone therapy has additional benefits in expediting complete DFU healing, reducing the amputation rates, and decreasing hospital length of stay, though its effects do not differ from standard treatments for complete ulcer resolution. Further research is needed to address the heterogeneity among studies and to better understand the potential beneficial effects of ozone therapy.

Measuring 24-h use of time in people with a diabetes-related foot ulcer: A feasibility study.

BACKGROUND: Physical activity (PA), sleep and sedentary time are now recognised as mutually exclusive and exhaustive parts of the 24-h day-if PA decreases, time spent sleeping, being sedentary or both must increase so that all components equate to 24 h. Recent advances in time-use epidemiology suggest that we should not consider time-use domains (PA, sleep and sedentary time) in isolation from each other, but in terms of a composition-the mix of time-use domains across the 24-h day. While interrelated daily activities are known to be important in the management of diabetes mellitus, few studies have investigated the interrelated daily activities in people with an active diabetes-related foot ulcer (DFU) and their impact on important outcomes such as wound severity, blood glucose control and health-related quality of life (HRQoL). This feasibility study aims to determine the acceptability and practicality of measuring 24-h use of time data in people with a DFU and its associations on important outcome measures for this population. METHODS: Participants wore a wrist-worn accelerometer for two weeks and completed demographic and HRQoL questionnaires. Outcomes were participant engagement, reported levels of study burden and value and compositional data analysis as a methodological approach for evaluating 24-h use of time data. RESULTS: Twenty-six participants reported low levels of study burden and rated the study value highly. The protocol appears feasible in terms of recruitment (81%) and retention rate (86%). On average, participants were relatively sedentary spending 747, 172 and 18 min in sedentary time, light physical activity and moderate-to-vigorous activity, respectively. Sleep appeared adequate with participants obtaining an average of 485 min, but quality of sleep was notably poor with average sleep efficiency of 75%. Compositional data analysis was able to quantify the integrated associations of 24-h use of time with HRQoL. CONCLUSION: The protocol provides an acceptable method to collect 24-h use of time data in people with a DFU. Efforts to consider and analyse PA as part of a 24-h activity composition may provide holistic and realistic understandings of PA in this clinical population.

Decreasing lifetime prevalence of diabetes-related foot ulcers in Norway: repeated cross-sectional population-based surveys from the HUNT study (1995-2019).

Background and aims: Diabetes-related foot ulcers (DFU) are a persistent healthcare challenge, impacting both patients and healthcare systems, with adverse effects on quality of life and productivity. Our primary aim was to examine the trends in lifetime prevalence of DFU, as well as other micro- and macrovascular complications in the Trøndelag Health Study (HUNT) in Norway. Methods: This study consists of individuals ≥20 years with diabetes participating in the population-based cross-sectional HUNT surveys (1995-2019). Prevalence ratios, comparing the lifetime prevalence of DFU and other relevant micro- and macrovascular complications between the HUNT surveys, were calculated using Poisson regression. Results: The lifetime prevalence (95% confidence interval (CI)) of a DFU requiring three or more weeks to heal was 11.0% (9.5-12.7) in HUNT2, 7.5% (6.3-8.8) in HUNT3 and 5.3% (4.4-6.3) in HUNT4. The decrease in DFU prevalence from 1995 to 2019 was observed in both men and women, for all age groups, and for both type 1 and type 2 diabetes. The highest lifetime prevalence of DFU was found among those with type 1 diabetes. The decrease in HbA1c from HUNT2 to HUNT4 did not differ between those with and without a DFU. The prevalence of chronic kidney disease (eGFR <60 mL/min/1.73 m2 (eGFR categories G3-G5)) increased in both individuals with and without a DFU. Conclusion: Results from the HUNT surveys show a substantial decline in the lifetime prevalence of DFU from 1995 to 2019.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Health-related quality of life in people with different diabetes-related foot ulcer health states: A cross-sectional study of healed, non-infected, infected, hospitalised and amputated ulcer states.

AIMS: Diabetes-related foot ulcers (DFU) are a leading cause of infection, hospitalisation and amputation. However, to our knowledge no studies have compared the health-related quality of life (HRQoL) of people with DFU that were infected, hospitalised or amputated. This study aimed to investigate and compare the HRQoL of different groups of people with healed, non-infected, infected, hospitalised, or amputated DFU. METHODS: This was a multi-centre cross-sectional study measuring the HRQoL of patients, attending one of 18 Diabetic Foot Services across Queensland, Australia, with one of five DFU health states: healed, non-infected, infected, hospitalised, amputated. HRQoL was measured using the EQ-5D-5L to estimate age-sex adjusted utility values. RESULTS: Of 376 included patients (mean age 63 (12) years, 75% male), age-sex adjusted HRQoL utility estimates (95% CIs) were: healed DFU 0.57 (0.51-0.64), non-infected DFU 0.55 (0.49-0.62), infected DFU 0.45 (0.36-0.55), hospitalised DFU 0.53 (0.42-0.64), and amputated DFU 0.55 (0.46-0.63). CONCLUSION: People in any DFU health state have considerably reduced HRQoL, with greatest reductions in those with infected DFU. These findings provide valuable HRQoL estimates and comparisons for several different important DFU health states, adding to our understanding of the impact of DFU on HRQoL and facilitating future economic evaluations.

Factors Associated With Foot Self-Care in Patients With Diabetes-Related High-Risk Feet: A Cross-Sectional Design.

Foot self-care has been commonly studied among people with diabetes. Previous research on foot self-care among those with diabetes-related high-risk feet is almost unavailable or very limited. The current study aims to fill this gap and provide a contemporary unprecedented analysis of this area of specialization. To assess the levels of, and factors associated with foot self-care among people with diabetes-related high-risk feet. A multi-center cross-sectional study from Jordan assessed the foot self-care of 107 participants with diabetes-related high-risk feet. Multiple socio-demographic, physiological, and psychosocial factors were collected, and the Arabic version of the diabetes foot self-care behavior scale was used to estimate the foot self-care of the study population. A multiple linear regression model was employed to identify factors associated with foot self-care. The mean score of foot self-care was 25.4 ± 7.1 (35 is the highest) indicating ~73% of adherence to foot self-care. Factors associated with higher foot self-care were being treated at the King Abdullah University Hospital (ß = .30, P < .01) and reporting higher scores of patients' interpretations about neuropathy physical causes of foot ulcers (ß = ".22," P = .02). People with diabetes-related high-risk feet reported a relatively adequate foot self-care practice. However, clinicians are still required to enhance foot self-care among this population. Health promotion programs may benefit from engaging people in understanding the pathophysiology of diabetes-related foot ulcers to improve foot self-care practices.

Decision-making processes for non-emergency diabetes-related lower extremity amputations: A scoping review.

Living with a diabetes-related foot ulcer has significant lifestyle impacts. Whilst often considered a last resort, amputation can overcome the burden of ulcer management, for an improved quality of life. However, limited research has been conducted to understand how the decision to amputate is made for people with a chronic ulcer when amputation is not required as a medical emergency. Therefore, the aim was to identify and map key concepts in the literature which describe the decision-making for diabetes-related amputations. This review followed Arksey and O'Malley's PRISMA scoping review framework. Five electronic databases and grey literature were searched for papers which described clinical reasoning and/or decision-making processes for diabetes-related amputation. Data were extracted and mapped to corresponding domains of the World Health Organisation's International Classification of functioning, Disability and Health (ICF) framework. Ninety-four papers were included. Personal factors including emotional wellbeing, quality of life, and treatment goals are key considerations for an elective amputation. It is important to consider an individual's lifestyle and personal circumstances, as well as the pathology when deciding between amputation or conservative management. This highlights the importance of a holistic and shared decision-making process for amputation which includes assessment of a person's lifestyle and function.

The Intersocietal IWGDF, ESVS, SVS Guidelines on Peripheral Artery Disease in People With Diabetes Mellitus and a Foot Ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes mellitus and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Comparative efficacy of growth factor therapy in healing diabetes-related foot ulcers: A network meta-analysis of randomized controlled trials.

INTRODUCTION: This study examined the relative efficacy of growth factor therapies in healing diabetes-related foot ulcers (DFU). METHODS: PubMed and Cochrane databases were searched for randomized controlled trials testing growth factor therapies for treating DFU. The primary outcome was complete wound closure. Results were reported as relative risk (RR) ± 95% credible intervals (CrI). The risk of bias was assessed using Cochrane's RoB-2 tool. RESULTS: A total of 31 RCTs involving 2174 participants were included. Only 13 of the trials (n = 924) reported on the aetiology of the ulcers (85.4% neuropathic and 14.6% ischaemic). Epidermal growth factor (RR 3.83; 95% CrI 1.81, 9.10), plasma-rich protein (PRP) (RR 3.36; 95% CrI 1.66, 8.03) and platelet-derived growth factor (PDGF) (RR 2.47; 95% CrI 1.23, 5.17) significantly improved the likelihood of complete ulcer healing compared to control. Sub-analyses suggested that PRP (3 trials - RR 9.69; 95% CrI 1.37, 103.37) and PDGF (6 trials - RR 2.22; 95% CrI 1.12, 5.19) significantly improved the likelihood of wound closure amongst trial mainly recruiting participants with neuropathic ulcers. Eleven trials had a low risk of bias, 9 had some concerns and 11 had a high risk of bias. Sub-analysis of trials with a low risk of bias suggested that none of the growth factors significantly improved ulcer healing compared with control. DISCUSSION: This network meta-analysis found low-quality evidence that Epidermal growth factor, PRP and PDGF therapy improved DFU healing likelihood compared with control. Larger well-designed trials are needed.

Diabetes-related foot disease: new insights with an antipodean focus.

Diabetes-related foot disease (DFD), defined as ulceration, infection or destruction of tissues of the foot in a person with current or previously diagnosed diabetes mellitus, is associated with a heavy burden for both patients and the healthcare system with high morbidity, mortality and costs. Improved outcomes for people with DFD are achieved with an interdisciplinary approach and adherence to best practice clinical guidelines; however, in the Australian context, the vastness of the country presents unique challenges in achieving optimal outcomes for all people with DFD, with variation in service delivery, availability and accessibility between metropolitan, rural and remote areas. Aboriginal and Torres Strait Islander Australians and people with diabetes living in rural and remote areas experience higher rates of lower-extremity amputation, and further efforts and resources are required to improve outcomes for these high-risk groups. In recent years, there have been advances in knowledge, including the understanding of the pathogenesis of diabetes-related peripheral neuropathy, genetic polymorphisms and mechanisms of disease associated with acute Charcot neuroarthropathy, biomarkers and potential mediators of diabetes-related foot ulcer (DFU) healing, the microbiology and microbiome profile of DFUs, pressure assessment and management as well as an expanded understanding of DFU sequelae and comorbidities. In this review, we describe new insights into pathophysiology, sequelae and comorbidities of DFD with a focus on basic and translational aspects and contributions to the field from Australian and New Zealand DFD researchers.

Rehabilitation for people wearing offloading devices for diabetes-related foot ulcers: a systematic review and meta-analyses.

BACKGROUND: Offloading devices improve healing of diabetes-related foot ulcers (DFUs) but they can limit mobilisation. Rehabilitation during or after removal of these devices may promote physical activity in a population at risk of poor health outcomes for which inactivity is a reversible risk factor. METHODS: This systematic review examined the effectiveness of rehabilitation interventions to promote physical activity during and/or after wearing an offloading device to treat diabetes-related foot ulcers. Searches using MESH terms and free-text combinations: 'foot ulcer', 'diabetic foot', 'casts, surgical', 'orthotic devices' were applied to MEDLINE, Embase, The Cochrane Library and clinical trial registers for randomised and observational studies published to September 2022. Methodological quality assessment of included studies was undertaken using the Cochrane Risk of Bias (RoB 2.0) and Risk of Bias In Non-randomised studies of Interventions (ROBINS-I) tools. RESULTS: Of 3332 records identified, eight studies (441 participants), four clinical trials and four cohort studies, were included. None delivered or tested a structured rehabilitation programme, but all reported physical activity outcomes during or after device use. People wearing non-removable total contact casts were less active than those wearing devices (SMD -0.45; 95% CI - 0.87 to - 0.04; p = 0.03; I2 56%; 4 trials). Diabetes-related foot ulcers in people wearing total contact casts were more likely to heal compared to removable devices at 12 weeks (OR 2.69; 95% CI 0.97 to 7.45; p = 0.06; I2 = 64%; 4 trials) and 20 weeks (OR 2.35; 95% CI 0.95 to 5.82; p = 0.07; I2 = 65%; 4 trials). CONCLUSIONS: Despite physical activity being low throughout off-loading treatment, no studies have specifically tested rehabilitation. There is a need to investigate the clinical and cost-effectiveness of rehabilitation programmes in this population. High quality trials are needed to provide robust evidence to support to rehabilitation after DFU treatment.

Differences in adherence to using removable cast walker treatment during daytime and nighttime weight-bearing activities in people with diabetes-related foot ulcers.

Aims: Patients' adherence to using knee-high offloading treatment is critical to effective healing of diabetes-related foot ulcers (DFUs). Previous studies have found that patients generally have low adherence to using removable knee-high offloading treatments, yet no study has investigated whether their adherence differs during daytime and nighttime. This study aimed to investigate the levels and factors associated with adherence to using knee-high removable cast walker (RCW) treatment during daytime and nighttime weight-bearing activities in people with DFUs. Methods: This was a secondary analysis of data collected from a multi-centre cross-sectional study investigating adherence to using knee-high RCWs among 57 participants with DFUs. All participants had multiple socio-demographic, physiological and psychosocial factors collected, before having their adherence to using RCWs during weight-bearing activity monitored over a 1-week period using the dual activity monitor method. Adherence data were categorised into daytime (06:00-18:00) and nighttime (18:00-06:00) periods and calculated separately. Multiple linear regression was used to identify factors associated with daytime and nighttime adherence. Results: Mean adherence to using RCW during weight-bearing activities in people with DFUs was higher during daytime compared with nighttime [39.9% (SD = 18.9) versus 20.4% (SD = 16.7), p < 0.001]. Factors independently associated with lower adherence during daytime were being male, longer diabetes duration, not having peripheral artery disease (PAD), and higher perceived RCW heaviness. Factors associated with lower adherence during nighttime were higher mean daytime steps, not having retinopathy and having dyslipidaemia. Conclusions: Adherence to using RCWs during weight-bearing activities reduced significantly at nighttime compared with daytime among people with DFUs, and this was associated with different factors. Interventions to improve adherence, in research and clinical practice, should incorporate methods to target daytime or nighttime adherence specifically.

In vivo observations of biofilm adhering to a dialkylcarbamoyl chloride-coated mesh dressing when applied to diabetes-related foot ulcers: A proof of concept study.

In this proof-of-concept study of twenty participants, we sought to determine if a DACC (Dialkylcarbamoyl chloride)-coated mesh dressing demonstrates an ability to adhere biofilm when placed on Diabetes Related Foot Ulcers (DRFUs) with chronic infection. The study also sought to determine if removal of the DACC-coated mesh dressings contributes to reducing the total number of bacteria in DRFUs, by exploring the total microbial loads, microbial community composition, and diversity. Standard of care was provided in addition to the application of DACC or DACC hydrogel every three days for a total of two weeks. Wound swabs, tissue curettage, and soiled dressings were collected pre and post-treatment. Tissue specimens obtained pre-treatment were analysed with scanning electron microscopy (SEM) and peptide nucleic acid fluorescent in situ hybridisation (PNA-FISH) with confocal laser scanning microscopy and confirmed the presence of biofilm in all DRFUs. SEM confirmed the presence of biofilms readily adhered to soiled DACC-coated mesh dressings pre- and post-treatment in all participants. Real-time quantitative polymerase chain reaction (qPCR) demonstrated the mean total microbial load of DRFUs in 20 participants did not change after two weeks of therapy (pre-treatment = 4.31 Log10 16 S copies (±0.8) versus end of treatment = 4.32 Log10 16 S copies (±0.9), P = .96, 95% CI -0.56 to 0.5). 16 S sequencing has shown the microbial composition of DACC dressings and wound swabs pre- and post-treatment remained similar (DACC; R = -.047, P = .98, Swab; R = -.04, P = .86), indicating the microbial communities originate from the ulcer. Biofilms adhere to DACC-coated mesh dressings; however, this may not reduce the total microbial load present within DRFU tissue. Wound dressings for use in hard-to-heal wounds should be used as an adjunct to a good standard of care which includes debridement and wound bed preparation.

Routine bacterial culture of proximal bone specimens during minor amputation in patients with diabetes-related foot infections has little clinical utility in predicting re-operation or ulcer healing.

BACKGROUND: Trans-phalangeal and trans-metatarsal amputation, collectively termed 'minor amputations' are important procedures for managing infections of diabetes-related foot ulcers (DFU). Following minor amputation, international guidelines recommend a prolonged course of antibiotics if residual infected bone on intra-operative bone samples are identified, but the quality of the evidence underpinning these guidelines is low. In this study, we examined the concordance of microbiological results from proximal bone cultures compared to results from superficial wound swabs in relation to patient outcomes; with the aim of determining the utility of routinely obtaining marginal bone specimens. METHODS: Data was retrospectively collected on 144 individuals who underwent minor amputations for infected DFU at a large Australian tertiary hospital. Concordance was identified for patients with both superficial wound swabs and intra-operative bone samples available. Patient outcomes were monitored up to 6 months post-amputation. The primary outcome was complete healing at 6 months; and secondary outcome measures included further surgery and death. Mann Whitney U testing was performed for bivariate analyses of continuous variables, Chi-Squared testing used for categorical variables and a logistic regression was performed with healing as the dependent variable. RESULTS: A moderate-high degree of concordance was observed between microbiological samples, with 38/111 (35%) of patients having discordant wound swab and bone sample microbiology. Discordant results were not associated with adverse outcomes (67.2% with concordant results achieved complete healing compared with 68.6% patients with discordant results; P = 0.89). Revascularisation during admission (0.37 [0.13-0.96], P = 0.04) and amputation of the 5th ray (0.45 [0.21-0.94], P = 0.03) were independent risk factors for non-healing. CONCLUSION: There was a moderate-high degree of concordance between superficial wound swab results and intra-operative bone sample microbiology in this patient cohort. Discordance was not associated with adverse outcomes. These results suggest there is little clinical utility in routinely collecting proximal bone as an adjunct to routine wound swabs for culture during minor amputation for an infected DFU.

Australian guideline on wound healing interventions to enhance healing of foot ulcers: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Diabetes-related foot ulceration (DFU) has a substantial burden on both individuals and healthcare systems both globally and in Australia. There is a pressing need for updated guidelines on wound healing interventions to improve outcomes for people living with DFU. A national expert panel was convened to develop new Australian evidence-based guidelines on wound healing interventions for people with DFU by adapting suitable international guidelines to the Australian context. METHODS: The panel followed National Health and Medical Research Council (NHMRC) procedures to adapt suitable international guidelines by the International Working Group of the Diabetic Foot (IWGDF) to the Australian context. The panel systematically screened, assessed and judged all IWGDF wound healing recommendations using ADAPTE and GRADE frameworks for adapting guidelines to decide which recommendations should be adopted, adapted or excluded in the Australian context. Each recommendation had their wording, quality of evidence, and strength of recommendation re-evaluated, plus rationale, justifications and implementation considerations provided for the Australian context. This guideline underwent public consultation, further revision and approval by ten national peak bodies. RESULTS: Thirteen IWGDF wound healing recommendations were evaluated in this process. After screening, nine recommendations were adopted and four were adapted after full assessment. Two recommendations had their strength of recommendations downgraded, one intervention was not currently approved for use in Australia, one intervention specified the need to obtain informed consent to be acceptable in Australia, and another was reworded to clarify best standard of care. Overall, five wound healing interventions have been recommended as having the evidence-based potential to improve wound healing in specific types of DFU when used in conjunction with other best standards of DFU care, including sucrose-octasulfate impregnated dressing, systemic hyperbaric oxygen therapy, negative pressure wound therapy, placental-derived products, and the autologous combined leucocyte, platelet and fibrin dressing. The six new guidelines and the full protocol can be found at: https://diabetesfeetaustralia.org/new-guidelines/ CONCLUSIONS: The IWGDF guideline for wound healing interventions has been adapted to suit the Australian context, and in particular for geographically remote and Aboriginal and Torres Strait Islander people. This new national wound healing guideline, endorsed by ten national peak bodies, also highlights important considerations for implementation, monitoring, and future research priorities in Australia.

Multiple factors predict longer and shorter time-to-ulcer-free in people with diabetes-related foot ulcers: Survival analyses of a large prospective cohort followed-up for 24-months.

AIMS: To investigate factors independently associated with time-to-(being)-ulcer-free, time-varying effects and predict adjusted ulcer-free probabilities, in a large prospective cohort with diabetes-related foot ulcers (DFU) followed-up for 24 months. METHODS: Patients presenting with DFU(s) to 65 Diabetic Foot Services across Queensland, Australia, between July-2011 and December-2017 were included. Demographic, comorbidity, limb, ulcer, and treatment factors were captured at presentation. Patients were followed-up until ulcer-free (all DFU(s) healed), amputation, death or two years. Factors associated with time-to-ulcer-free were investigated using both Cox proportional hazards and flexible parametric survival models to explore time-varying effects and plot predicted adjusted ulcer-free probability graphs. RESULTS: Of 4,709 included patients (median age 63 years, 69.5% male), median time-to-ulcer-free was 112 days (IQR:40->730), with 68.4% ulcer-free within two years. Factors independently associated with longer time-to-ulcer-free were each year of age younger than 60 years, living in a regional or remote area, smoking, neuropathy, peripheral artery disease (PAD), ulcer size >1 cm2, deep ulcer and mild infection (all p < 0.05). Time-varying effects were found for PAD and ulcer size limiting their association to six months only. Shorter time-to-ulcer-free was associated with recent DFU treatment by a podiatrist and receiving knee-high offloading treatment (both p < 0.05). Predicted adjusted ulcer-free probability graphs reported largest differences in time-to-ulcer-free over 24-months for geographical remoteness and PAD factors. CONCLUSIONS: Multiple factors predicted longer and shorter time-to-ulcer-free in people presenting with DFUs. Considering these factors, their time-varying effects and adjusted ulcer-free probability graphs, should aid the prediction of the likely time-to-(being)-ulcer-free for DFU patients.

Pressure relieving interventions for the management of diabetes-related foot ulcers: a study from the Northern Territory of Australia.

BACKGROUND: Offloading intervention is an important component in the management of diabetes-related foot ulcer (DFU). The NT population is unique with certain distinctive challenges. Potential advantages of and barriers to optimal offloading methods in our setting were investigated. METHODS: Consecutive patients with DFU treated with offloading devices between 2003 and 2015 at the Multidisciplinary Foot Clinic (MDFC), Royal Darwin Hospital were included. The outcome measures were healing, amputation and discontinuation. Risk factors for offloading failure were studied. RESULTS: Total contact cast (TCC) was the most common offloading used (n = 175). The other removable non-TCC devices used were therapeutic footwear (n = 74), CamWalker (n = 35), and orthotic devices (n = 43). The overall healing rate was 88.7%. Healing rates were higher (93.2% versus 83.5%, P < 0.05) and amputation rates were lower (4.0% versus 7.3%, P = 0.026) in the TCC group than in the removable non-TCC group. The mean duration of offloading was longer in the TCC group (3.6 ± 1.5 versus. 3.2 ± 1.5 months, P = 0.008). Wagner grade ≥ 2 and removable non-TCC devices were significant risk factors for offloading failure. CONCLUSION: Patients treated with TCC had higher healing rates than those treated with removable non-TCC devices. The duration of offloading was longer than reported in other studies. Higher Wagner grade and removable non-TCC devices were risk factors for offloading failure. Non-removable offloading devices are the first choice in diabetes-related neuropathic ulcers.

Management of diabetes-related foot disease in the outpatient setting during the COVID-19 pandemic.

The use of telephone and/or video consultation in routine management of acute diabetes-related foot disease (DFD) before the coronavirus disease 2019 (COVID-19) pandemic at a tertiary hospital is unprecedented. In March 2020, the Diabetes Feet Australia (DFA) released a national guideline to inform DFD management during the COVID-19 pandemic. The present study aimed to describe the adherence to the DFA guideline of managing acute DFD using telephone and/or video consultation at a Western Australian tertiary hospital during this period. We found >80% adherence rate to the DFA guideline and the management of active DFD using telephone and/or video consultations was feasible and acceptable in carefully selected patients.