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

Diabetes‐related foot disease (DFD) — foot ulcers, infection and ischaemia — is a leading cause of hospitalisation, amputation, disability, and health care costs.1,2,3,4,5,6 In Australia each year, DFD affects around 50 000 people, causing 28 000 hospitalisations, 5000 amputations and $1.6 billion in costs.1,2,3,4,5 Further, 300 000 Australians are at risk of DFD, and Aboriginal and Torres Strait Islander Peoples have up to a 38‐fold risk of developing DFD and ensuing amputations.1,2,3,4,7

Despite the large national DFD burden, Australian regions implementing guideline‐based care have demonstrated large reductions in their regional DFD burdens and costs.4,8,9,10,11 However, the most recent Australian guideline on DFD was published in 2011,12 many of its recommendations are now outdated,1,13 and the body of research on DFD has since expanded considerably.14 Therefore, the recent Australian DFD Strategy recommended an urgent update of Australian DFD guideline to inform contemporary evidence‐based practice and help reduce the large burden of DFD.1,2

To address this gap, Diabetes Feet Australia (DFA; a division of the Australian Diabetes Society) recently developed and published a suite of six new guidelines that make up the new Australian evidence‐based guidelines for the prevention and management of DFD. The six full guidelines are available at https://jfootankleres.biomedcentral.com/.15,16,17,18,19,20,21

Methods

The methodology for developing these guidelines is detailed in a published protocol.15 In brief, as the funding necessary to develop guidelines de novo was unavailable, DFA appointed a guidelines development group comprising multidisciplinary clinical, research, guideline, consumer and Aboriginal and Torres Strait Islander experts in DFD to adapt suitable international guidelines to the Australian context.15 Experts were defined as having nationally or internationally recognised track records in DFD research, guideline development, or lived experience. This group developed the protocol following eight key steps adhering to the ADAPTE and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approaches as recommended by the National Health and Medical Research Council (NHMRC) guidelines for adopting or adapting international guidelines.22,23,24

First, the scope was defined to develop new evidence‐based guidelines that informed the practice of the multidisciplinary health professionals that provide prevention or management for populations with or at risk of DFD in the Australian context. DFD was defined as infection, ulceration, or tissue destruction of the foot in a person with diabetes.25,26 Second, a systemic search was undertaken to identify all international DFD guidelines in international and Australian guideline registers by three independent authors (PAL, AR and JP). Third, all international guidelines identified were assessed independently by four authors (PAL, AR, JP and RJC) for quality using a 23‐item Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, plus suitability and currency using a 22‐item instrument customised from the NHMRC table of factors to consider when adapting guidelines.15,22,27 The suite of six International Working Group on the Diabetic Foot (IWGDF) guidelines,28,29,30,31,32,33,34 along with their accompanying systematic reviews of all relevant studies in the field,35,36,37,38,39,40,41,42,43,44 were identified as the only international DFD guidelines with appropriate quality, suitability and currency to adapt.

Fourth, all 100 recommendations (and associated rationale) in the IWGDF guidelines were systematically evaluated.28,29,30,31,32,33,34 This was undertaken by six panels each comprising six to eight nationally and internationally recognised experts in the DFD fields of prevention, classification, peripheral artery disease (PAD), infection, offloading, and wound healing interventions.15 Collectively, the panels comprised 30 experts from endocrinology, infectious diseases, vascular surgery, orthopaedic surgery, wound care nursing, podiatry, pedorthics, consumers, and Aboriginal and Torres Strait Islander peoples. Each panel rated all recommendations in their field for acceptability and applicability in the Australian context using a seven‐item ADAPTE form by consensus.24 Where panels rated all seven items as acceptable or applicable, the recommendation was adopted. Where panels rated any item as unsure or not acceptable or applicable, the panel performed a full re‐evaluation of the recommendation using the GRADE Evidence to Decision framework to facilitate judgements on eight important criteria: the problem, desirable effects, undesirable effects, quality of evidence, values, balance of effects, acceptability, and feasibility.15,23 A decision was made to adopt, if all panel and IWGDF criteria judgements were in agreement; adapt, if some disagreements; or exclude, if substantial disagreements.15

Fifth, panels redrafted recommendations (and rationale) using the GRADE approach.15,23 For adopted recommendations, the wording, strength of recommendation and quality of evidence remained the same. For adapted recommendations, the wording was redrafted to be clear, specific and unambiguous on what was recommended.15,23 The strength of recommendation was re‐evaluated as “strong” or “weak”, based on the extent to which the panel was confident that the desirable effects (benefits) of the intervention clearly outweighed the undesirable effects (harms), based on the available evidence, applicability and feasibility in the Australian context.15,23 A strong recommendation implies the desirable effects of the intervention clearly outweigh the undesirable effects, and most people in this situation would be best served using this recommendation.15,23 A weak recommendation implies the desirable effects probably outweigh the undesirable effects, but there is a need to carefully consider each person's situation before using.15,23 Quality of evidence was re‐evaluated as high, moderate, low or very low, based on the extent the panel could be certain that the true effect was close to the effect estimates found for the critical outcomes in the available evidence supporting the recommendation and further research was unlikely to change their certainty.15,23 For excluded recommendations, the panel stated the recommendation was excluded. The panel then drafted rationale for all decisions, plus considerations on implementing the recommendation in Australia (including specifically for geographically remote and Aboriginal and Torres Strait Islander peoples), monitoring and future research priorities.15,23

Sixth, panels drafted and incorporated all recommendations and rationale in a full guideline consultation manuscript. Seventh, each panel sought four to six weeks of public consultation on their consultation manuscript, collated feedback, transparently revised and sought endorsement from national peak bodies.15 Finally, panels incorporated all recommendations into pathways to aid implementation into practice,15 with pathways further developed into interactive online decision‐assisting pathways and a practical toolkit, available in full at https://www.diabetesfeetaustralia.org/new‐guidelines/.

Recommendations

Here we summarise the key recommendations considered most relevant for the general medical audience, with a focus on prevention and classification.16,17,18,19,20,21,45 In doing so, we highlight that many PAD, infection, offloading and wound healing management recommendations that are considered most relevant for specialist medical audiences have been omitted.16,17,18,19,20,21 Thus, we strongly suggest people with DFD are referred to interdisciplinary High Risk Foot Services or equivalent for management where possible.16,17,18,19,20,21

We also tabulated recommendations that are new or changed from the previous 2011 guideline along with their GRADE strength of recommendation and quality of evidence (Box 1, Box 2, Box 3, Box 4, Box 5 and Box 6). We further edited the tabulated recommendations for brevity and flow, and we refer the reader to the full guidelines for complete details on each recommendation, including rationale, implementation, monitoring, and research considerations.16,17,18,19,20,21 Otherwise, we highlight that most recommendations for DFD apply to healing or non‐healing DFD; we denote recommendations specifically for non‐healing DFD in Box 3, Box 4, Box 5 and Box 6.26

The most obvious change in the new guidelines is that they contain 98 recommendations across six DFD fields, whereas the previous guideline contained 25 recommendations across four DFD fields. The new guidelines also used the recommended GRADE methodological approach, whereas the previous used the historical NHMRC approach. Finally, these new guidelines have been endorsed by ten national peak bodies, including the Australian Diabetes Society, the Australian and New Zealand Society for Vascular Surgery, the Australasian Society for Infectious Diseases, the Australian Podiatry Association, and Wounds Australia.16,17,18,19,20,21,45

Prevention

There are 15 prevention recommendations covering screening, education, self‐care, footwear and treatments for people at risk of DFD (Box 1 and Box 7).16 It is recommended that people with diabetes are screened at least annually for loss of protective sensation (LOPS) and PAD to determine any increased risk of diabetes‐related foot ulcers (DFU). For LOPS, this can be performed using a 10 g Semmes–Weinstein monofilament or Ipswich Touch Test; and for PAD, by taking a relevant history and palpating foot pulses.16,18 People identified to not have LOPS or PAD can be categorised at very low risk of DFU and rescreened in 12 months. Individuals identified to have LOPS or PAD should be further examined according to the IWGDF risk stratification system for foot deformities, abundant callus, pre‐ulcerative lesions, DFU history, amputation history, end‐stage renal disease, and DFU (Box 7). This examination categorises if the person is at low risk (and re‐examined every six to 12 months), moderate risk (re‐examined every three to six months), or high risk of DFU (re‐examined every one to three months) according to the IWGDF risk stratification system.16 For people with DFU, see the Classification section.17 These categories are based on systematic reviews finding increasing combinations of these risk factors (and risk categories) correspond with increasing likelihood of developing DFU.42,43 We note the IWGDF system is a change to the system in the previous guideline,12 as it includes end‐stage renal disease as an additional risk factor found to predict DFU development, and four risk categories with different combinations of risk factors instead of three in the previous guideline.16 The IWGDF risk stratification system should be considered the minimum standard to document and communicate risk of DFU with other health professionals (Box 7).16

For individuals identified at risk (low, moderate or high), education is recommended on DFU risk, foot self‐care (including daily inspection for foot problems), foot protection (including wearing well fitting footwear), regular foot examinations (as per above re‐examination recommendations), and how to seek care if a DFU is identified. In people looking to increase activity, a gradual increase in weight‐bearing activity while wearing appropriate well fitted footwear and daily inspection for foot problems is recommended. Further, treatment is recommended for any pre‐ulcerative lesions, callus, ingrown toenails and fungal infections, and prescription of orthotic interventions considered to reduce abundant callus.16

For people at moderate or high risk, prescribing medical‐grade footwear and instructing patients to self‐monitor foot skin temperatures daily to detect signs of pre‐ulcerative lesions (when systems become available in Australia) are also recommended. Further, for individuals at high risk, it is strongly recommended that medical‐grade footwear with demonstrated plantar pressure‐relieving effects be prescribed. Otherwise, if the above recommended non‐surgical treatment fails to reduce ongoing abundant callus or recurrent DFU, the use of various surgical interventions for the prevention of DFU should be considered.16

Classification

There are five classification recommendations covering ulcer, infection, ischaemia and auditing (Box 2 and Box 8).17 The Site, Ischaemia, Neuropathy, Bacterial Infection, Area and Depth (SINBAD) wound classification system is strongly recommended as the minimum standard to document and communicate DFU characteristics with other health professionals (Box 8 and Supporting Information, eTable 1).17 We note that SINBAD is a change to the previous guideline that recommended the University of Texas wound classification system,12 as SINBAD has demonstrated more effective communication between health professionals, does not require any specialised equipment, and has higher quality of evidence. Thus, there should be no barriers to using SINBAD in the primary care context, including when referring people with DFU to interdisciplinary High Risk Foot Services. Further, it is recommended that SINBAD also be used as a minimum for any service audits to allow comparisons between institutions on DFU outcomes.17

In people with infected DFU, the Infectious Diseases Society of America (IDSA)/IWGDF infection classification system is recommended to classify severity and guide infection management (see Infection section).17,19 Additionally, in people with DFU who are being managed in settings with appropriate vascular expertise (such as interdisciplinary High Risk Foot Services), the Wound, Ischaemia and foot Infection (WIfI) classification system is recommended to aid decision making in the assessment of perfusion and likelihood of revascularisation benefit (see PAD section and Supporting Information, eTable 2).17,18

Otherwise, we highlight that classification using the above recommended systems is critical to achieving optimal outcomes for people with DFU, and important to facilitate effective communication among health professionals, referral, triage, and guide management decisions.17 Further, we point out that appropriate DFU classification is central to the below PAD, infection, offloading and wound healing management recommendations.18,19,20,21

Peripheral artery disease

There are 17 PAD recommendations covering diagnosis, severity classification, medical and surgical treatments for people with DFU (Box 3 and Supporting Information, eFigure 1).18 We note all are new, as no PAD recommendations were made in the previous guideline.12 In brief, it is recommended that all people with diabetes and DFU undergo at minimum a clinical examination for PAD, including relevant history and palpation of foot pulses.18 As clinical examination does not reliably exclude PAD, it is also strongly recommended that further non‐invasive bedside testing is performed, including pedal Doppler arterial waveforms, ankle systolic pressure, ankle brachial index (ABI) and/or toe systolic pressure. Vascular imaging and referral for possible revascularisation should always be considered for patients with a DFU and an ankle pressure below 50 mmHg, ABI below 0.5, or toe pressure below 30 mmHg. People with less severe ischaemia may also require revascularisation. Otherwise, it is strongly recommended that all centres treating DFU should have expertise in and/or rapid access to facilities necessary to diagnose and treat PAD.18

Infection

There are 35 infection recommendations covering diagnosis, severity classification, and medical and surgical treatments for people with DFU (Box 4 and Supporting Information, eFigures 2A and 2B).19 Again, we note all are new, as no infection recommendations were made in the previous guideline.12 In brief, it is recommended that foot infection is diagnosed clinically based on the presence of at least two signs and symptoms of local inflammation, including swelling/induration, erythema, tenderness/pain, warmth, or purulent discharge. If infection is diagnosed, it is strongly recommended that the IDSA/IWGDF classification system is used to classify severity as mild (involves only skin or subcutaneous tissue without erythema that extends > 2 cm around the DFU), moderate (involves deeper tissues and/or erythema that extends > 2 cm around the DFU) or severe (involves systemic manifestations of systemic inflammatory response syndrome). If osteomyelitis is suspected, a combination of the probe‐to‐bone test, erythrocyte sedimentation rate (or C‐reactive protein and/or procalcitonin) and plain x‐rays are recommended as the initial diagnostic studies. If the diagnosis remains in doubt, it is then recommended that advanced imaging studies be considered, such as magnetic resonance imaging scans. Diagnosis of foot infection severity informs the specific infection management recommendations (Box 4 and Supporting Information, eFigures 2A and 2B).19

Offloading

There are 13 recommendations covering offloading for different situations in people with DFU (Box 5, Box 9 and Supporting Information, eFigure 3).20 Offloading is defined as the relief of mechanical stress (pressure) from a specific area of the foot.20,31 We note nearly all recommendations are new, as only two offloading recommendations were made in the previous guideline.12 We also highlight that offloading management now has the strongest evidence to effectively heal DFU and should always be considered.15,46 In brief, for people with plantar DFU, it is strongly recommended that non‐removable knee‐high offloading devices (total contact cast or non‐removable knee‐high walker) should be provided as first line treatment unless contraindicated or not tolerated. If contraindicated (such as moderate infection) or not tolerated by the patient (such as unable to use for employment), then consider removable knee‐high offloading devices as second line treatment, removable ankle‐high offloading devices as third line, and medical‐grade footwear as last line. Otherwise, felted foam (or other pressure offloading insole) in combination with the chosen offloading device can be considered to further reduce plantar pressure. For people with non‐plantar DFU, depending on the DFU type and location, removable offloading devices, felted foam, toe spacers, or medical‐grade footwear are recommended. If non‐surgical offloading fails to heal a person with plantar DFU, various surgical offloading procedures should be considered, including Achilles tendon lengthening, gastrocnemius resections, metatarsal head resections, joint arthroplasty, or digital flexor tenotomies.20,38

Wound healing

There are 13 wound healing recommendations covering debridement, wound dressing selection, and other wound treatments in people with DFU (Box 6 and Supporting Information, eFigure 4).21 We note half of these recommendations are new compared with the previous guideline.12 The similar recommendations include:

• regular sharp debridement if not contraindicated;
• using wound dressings initially based on controlling exudate, comfort and cost;
• considering systemic hyperbaric oxygen therapy for ischaemic DFU; and
• considering negative pressure wound therapy for post‐surgical DFU.

The new recommendations for non‐healing DFU include considering the use of sucrose octasulfate‐impregnated dressings, placental‐derived products, or autologous combined leucocyte, platelet and fibrin dressings.21 However, we note these products have only been recently approved in Australia.21

Conclusion

For the first time in a decade, we have developed new Australian evidence‐based guidelines for DFD. These new guidelines have been endorsed by ten national peak bodies and we encourage all Australian medical professionals caring for people at risk of, or with DFD, to implement the recommendations contained in these new guidelines to help reduce the large patient and national burden of DFD in Australia.