Australian evidence-based guidelines for the prevention and management of diabetes-related foot disease: a guideline summary.

INTRODUCTION: Diabetes-related foot disease (DFD) - foot ulcers, infection, ischaemia - is a leading cause of hospitalisation, disability, and health care costs in Australia. The previous 2011 Australian guideline for DFD was outdated. We developed new Australian evidence-based guidelines for DFD by systematically adapting suitable international guidelines to the Australian context using the ADAPTE and GRADE approaches recommended by the NHMRC. MAIN RECOMMENDATIONS: This article summarises the most relevant of the 98 recommendations made across six new guidelines for the general medical audience, including: prevention - screening, education, self-care, footwear, and treatments to prevent DFD; classification - classifications systems for ulcers, infection, ischaemia and auditing; peripheral artery disease (PAD) - examinations and imaging for diagnosis, severity classification, and treatments; infection - examinations, cultures, imaging and inflammatory markers for diagnosis, severity classification, and treatments; offloading - pressure offloading treatments for different ulcer types and locations; and wound healing - debridement, wound dressing selection principles and wound treatments for non-healing ulcers. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINE: For people without DFD, key changes include using a new risk stratification system for screening, categorising risk and managing people at increased risk of DFD. For those categorised at increased risk of DFD, more specific self-monitoring, footwear prescription, surgical treatments, and activity management practices to prevent DFD have been recommended. For people with DFD, key changes include using new ulcer, infection and PAD classification systems for assessing, documenting and communicating DFD severity. These systems also inform more specific PAD, infection, pressure offloading, and wound healing management recommendations to resolve DFD.

Australian guideline on management of diabetes-related foot infection: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Diabetes-related foot infections cause substantial morbidity and mortality, both globally and in Australia. There is a need for up-to-date evidence-based guidelines to ensure optimal management of patients with diabetes-related foot infections. We aimed to identify and adapt high quality international guidelines to the Australian context to become the new Australian evidence-based guideline for people with a diabetes-related foot infection. METHODS: Following Australian National Health and Medical Research Council (NHMRC) procedures we identified the 2019 International Working Group on the Diabetic Foot (IWGDF) guidelines as suitable for adaptation to the Australian context. Guidelines were screened, assessed and judged by an expert panel for the Australian context using the guideline adaptation frameworks ADAPTE and Grading of Recommendations Assessment, Development and Evaluation (GRADE). Judgements led to recommendations being adopted, adapted or excluded, with additional consideration regarding their implementation, monitoring and future research for the Australian context. Clinical pathways were then developed to assist implementation. RESULTS: Of 36 original diabetes-related foot infection IWGDF sub-recommendations, 31 were adopted, four were adapted and one was excluded. Adaption was primarily undertaken due to differences or clarification of the sub-recommendations' intended population. One sub-recommendation was excluded due to substantial differences in judgements between the panel and IWGDF and unacceptable heterogeneity of the target population. Therefore, we developed 35 evidence-based sub-recommendations for the Australian context that should guide best practice diagnosis and management of people with diabetes-related foot infection in Australia. Additionally, we incorporated these sub-recommendations into two clinical pathways to assist Australian health professionals to implement these evidence-based sub-recommendations into clinical practice. The six guidelines and the full protocol can be found at: https://www.diabetesfeetaustralia.org/new-guidelines/ . CONCLUSIONS: A new national guideline for the diagnosis and management of people with diabetes-related foot infections were successfully developed for the Australian context. In combination with simplified clinical pathway tools they provide an evidence-based framework to ensure best management of individuals with diabetes-related foot infections across Australia and highlight considerations for implementation and monitoring.

Australian guideline on diagnosis and management of peripheral artery disease: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Peripheral artery disease (PAD) is implicated in up to 50% of diabetes-related foot ulcers (DFU) and significantly contributes to morbidity and mortality in this population. An evidence-based guideline that is relevant to the national context including consideration of the unique geographical and health care system differences between Australia and other countries, and delivery of culturally safe care to First Nations people, is urgently required to improve outcomes for patients with PAD and DFU in Australia. We aimed to identify and adapt current international guidelines for diagnosis and management of patients with PAD and DFU to develop an updated Australian guideline. METHODS: Using a panel of national content experts and the National Health and Medical Research Council procedures, the 2019 International Working Group on the Diabetic Foot (IWGDF) guidelines were adapted to the Australian context. The guideline adaptation frameworks ADAPTE and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were applied to the IWGDF guideline for PAD by the expert panel. Recommendations were then adopted, adapted or excluded, and specific considerations for implementation, population subgroups, monitoring and future research in Australia were developed with accompanying clinical pathways provided to support guideline implementation. RESULTS: Of the 17 recommendations from the IWGDF Guideline on diagnosis, prognosis and management of PAD in patients with diabetes with and without foot ulcers, 16 were adopted for the Australian guideline and one recommendation was adapted due to the original recommendation lacking feasibility in the Australian context. In Australia we recommend all people with diabetes and DFU undergo clinical assessment for PAD with accompanying bedside testing. Further vascular imaging and possible need for revascularisation should be considered for all patients with non-healing DFU irrespective of bedside results. All centres treating DFU should have expertise in, and/or rapid access to facilities necessary to diagnose and treat PAD, and should provide multidisciplinary care post-operatively, including implementation of intensive cardiovascular risk management. CONCLUSIONS: A guideline containing 17 recommendations for the diagnosis and management of PAD for Australian patients with DFU was developed with accompanying clinical pathways. As part of the adaptation of the IWGDF guideline to the Australian context, recommendations are supported by considerations for implementation, monitoring, and future research priorities, and in relation to specific subgroups including Aboriginal and Torres Strait Islander people, and geographically remote people. This manuscript has been published online in full with the authorisation of Diabetes Feet Australia and can be found on the Diabetes Feet Australia website: https://www.diabetesfeetaustralia.org/new-guidelines/ .

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.

Australian guideline on prevention of foot ulceration: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: There are no current Australian guidelines on the prevention of diabetes-related foot ulceration (DFU). A national expert panel aimed to systematically identify and adapt suitable international guidelines to the Australian context to create new Australian evidence-based guidelines on prevention of first-ever and/or recurrent DFU. These guidelines will include for the first-time considerations for rural and remote, and Aboriginal and Torres Strait Islander peoples. METHODS: The National Health and Medical Research Council procedures were followed to adapt suitable international guidelines on DFU prevention to the Australian health context. This included a search of public databases after which the International Working Group on the Diabetic Foot (IWGDF) prevention guideline was deemed the most appropriate for adaptation. The 16 IWGDF prevention recommendations were assessed using the ADAPTE and GRADE systems to decide if they should be adopted, adapted or excluded for the new Australian guideline. The quality of evidence and strength of recommendation ratings were re-evaluated with reference to the Australian context. This guideline underwent public consultation, further revision, and approval by national peak bodies. RESULTS: Of the 16 original IWGDF prevention recommendations, nine were adopted, six were adapted and one was excluded. It is recommended that all people at increased risk of DFU are assessed at intervals corresponding to the IWGDF risk ratings. For those at increased risk, structured education about appropriate foot protection, inspection, footwear, weight-bearing activities, and foot self-care is recommended. Prescription of orthotic interventions and/or medical grade footwear, providing integrated foot care, and self-monitoring of foot skin temperatures (contingent on validated, user-friendly and affordable systems becoming available in Australia) may also assist in preventing DFU. If the above recommended non-surgical treatment fails, the use of various surgical interventions for the prevention of DFU can be considered. CONCLUSIONS: This new Australian evidence-based guideline on prevention of DFU, endorsed by 10 national peak bodies, provides specific recommendations for relevant health professionals and consumers in the Australian context to prevent DFU. Following these recommendations should achieve better DFU prevention outcomes in Australia.

Guidelines development protocol and findings: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Diabetes-related foot disease (DFD) is a leading cause of the Australian disease burden. The 2011 Australian DFD guidelines were outdated. We aimed to develop methodology for systematically adapting suitable international guidelines to the Australian context to become the new Australian evidence-based guidelines for DFD. METHODS: We followed the Australian National Health Medical Research Council (NHMRC) guidelines for adapting guidelines. We systematically searched for all international DFD guideline records. All identified records were independently screened and assessed for eligibility. Those deemed eligible were further assessed and included if scoring at least moderate quality, suitability and currency using AGREE II and NHMRC instruments. The included international guidelines had all recommendations extracted into six sub-fields: prevention, wound classification, peripheral artery disease, infection, offloading and wound healing. Six national panels, each comprising 6-8 multidisciplinary national experts, screened all recommendations within their sub-field for acceptability and applicability in Australia using an ADAPTE form. Where panels were unsure of any acceptability and applicability items, full assessments were undertaken using a GRADE Evidence to Decision tool. Recommendations were adopted, adapted, or excluded, based on the agreement between the panel's and international guideline's judgements. Each panel drafted a guideline that included all their recommendations, rationale, justifications, and implementation considerations. All underwent public consultation, final revision, and approval by national peak bodies. RESULTS: We screened 182 identified records, assessed 24 full text records, and after further quality, suitability, and currency assessment, one record was deemed a suitable international guideline, the International Working Group Diabetic Foot Guidelines (IWGDF guidelines). The six panels collectively assessed 100 IWGDF recommendations, with 71 being adopted, 27 adapted, and two excluded for the Australian context. We received 47 public consultation responses with > 80% (strongly) agreeing that the guidelines should be approved, and ten national peak bodies endorsed the final six guidelines. The six guidelines and this protocol can be found at: https://www.diabetesfeetaustralia.org/new-guidelines/ CONCLUSION: New Australian evidence-based guidelines for DFD have been developed for the first time in a decade by adapting suitable international guidelines. The methodology developed for adaptation may be useful for other foot-related conditions. These new guidelines will now serve as the national multidisciplinary best practice standards of DFD care in Australia.

Australian guideline on offloading treatment for foot ulcers: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Pressure offloading treatment is critical for healing diabetes-related foot ulcers (DFU). Yet the 2011 Australian DFU guidelines regarding offloading treatment are outdated. A national expert panel aimed to develop a new Australian guideline on offloading treatment for people with DFU by adapting international guidelines that have been assessed as suitable to adapt to the Australian context. METHODS: National Health and Medical Research Council procedures were used to adapt suitable International Working Group on the Diabetic Foot (IWGDF) guidelines to the Australian context. We systematically screened, assessed and judged all IWGDF offloading recommendations using best practice ADAPTE and GRADE frameworks to decide which recommendations should be adopted, adapted or excluded in the Australian context. For each recommendation, we re-evaluated the wording, quality of evidence, strength of recommendation, and provided rationale, justifications and implementation considerations, including for geographically remote and Aboriginal and Torres Strait Islander peoples. This guideline, along with five accompanying Australian DFU guidelines, underwent public consultation, further revision and approval by ten national peak bodies (professional organisations). RESULTS: Of the 13 original IWGDF offloading treatment recommendations, we adopted four and adapted nine. The main reasons for adapting the IWGDF recommendations included differences in quality of evidence ratings and clarification of the intervention(s) and control treatment(s) in the recommendations for the Australian context. For Australians with plantar DFU, we recommend a step-down offloading treatment approach based on their contraindications and tolerance. We strongly recommend non-removable knee-high offloading devices as first-line treatment, removable knee-high offloading devices as second-line, removable ankle-high offloading devices third-line, and medical grade footwear as last-line. We recommend considering using felted foam in combination with the chosen offloading device or footwear to further reduce plantar pressure. If offloading device options fail to heal a person with plantar DFU, we recommend considering various surgical offloading procedures. For people with non-plantar DFU, depending on the type and location of the DFU, we recommend using a removable offloading device, felted foam, toe spacers or orthoses, or medical grade footwear. The six new guidelines and the full protocol can be found at: https://diabetesfeetaustralia.org/new-guidelines/ . CONCLUSIONS: We have developed a new Australian evidence-based guideline on offloading treatment for people with DFU that has been endorsed by ten key national peak bodies. Health professionals implementing these offloading recommendations in Australia should produce better DFU healing outcomes for their patients, communities, and country.

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

BACKGROUND: Wound classification systems are useful tools to characterise diabetes-related foot ulcers (DFU) and are utilised for the purpose of clinical assessment, to promote effective communication between health professionals, and to support clinical audit and benchmarking. Australian guidelines regarding wound classification in patients with DFU are outdated. We aimed to adapt existing international guidelines for wound classification to develop new evidence-based Australian guidelines for wound classification in people with diabetes and DFU. METHODS: Recommended NHRMC procedures were followed to adapt suitable International Working Group on the Diabetic Foot (IWGDF) guidelines on wound classification to the Australian health context. Five IWGDF wound classification recommendations were evaluated and assessed according to the ADAPTE and GRADE systems. We compared our judgements with IWGDF judgements to decide if recommendations should be adopted, adapted or excluded in an Australian context. We re-evaluated the quality of evidence and strength of recommendation ratings, provided justifications for the recommendation and outlined any special considerations for implementation, subgroups, monitoring and future research in an Australian setting. RESULTS: After the five recommendations from the IWGDF 2019 guidelines on the classification of DFUs were evaluated by the panel, two were adopted and three were adapted to be more suitable for Australia. The main reasons for adapting, were to align the recommendations to existing Australian standards of care, especially in specialist settings, to maintain consistency with existing recommendations for documentation, audit and benchmarking and to be more appropriate, acceptable and applicable to an Australian context. In Australia, we recommend the use of the SINBAD system as a minimum standard to document the characteristics of a DFU for the purposes of communication among health professionals and for regional/national/international audit. In contrast to the IWGDF who recommend against usage, in Australia we recommend caution in the use of existing wound classification systems to provide an individual prognosis for a person with diabetes and a foot ulcer. CONCLUSIONS: We have developed new guidelines for wound classification for people with diabetes and a foot ulcer that are appropriate and applicable for use across diverse care settings and geographical locations in Australia.