Question five (recommendation 10)

In a person with diabetes and foot ulceration, which diagnostic imaging modalities to obtain anatomical information are most useful when considering revascularisation?

Recommendation 10

Use any of the following modalities to obtain anatomical information when considering revascularising a patient’s lower extremity: colour duplex ultrasound (CDUS), computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or intra-arterial digital subtraction angiography (DSA). Evaluate the entire lower extremity arterial circulation with detailed visualisation of below-the-knee and pedal arteries, in an anteroposterior and lateral plane. (Strong; low).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel agreed with the IWGDF judgement on the strength of the recommendation (strong), with low quality of available evidence. Revascularisation of the lower limb should be guided by appropriate imaging of the entire lower limb arterial circulation including pedal circulation. Detailed visualisation of vessels below the knee and the pedal arteries is required due to increased likelihood of distally located disease in people with diabetes [15]. CDUS, MRA, CTA and DSA are all modalities that may be used to establish lower limb circulation in a patient with diabetes. The panel agreed the majority of Australian patients would prefer to undergo imaging. The panel agreed that the intervention is applicable to the Australian context and that there were no policy or legislative constraints on implementation of this recommendation. The panel noted that choice of imaging may be influenced by the availability of expertise and equipment, and patient specific factors (see below: implementation considerations), however, the panel considered there to be adequate expertise and equipment available in secondary and tertiary health care settings where patients typically access this care.

Implementation considerations General considerations

The panel agreed with the IWGDF that CDUS, CTA, MRA, or DSA could be used for evaluation of lower limb arterial circulation. Each form of imaging has specific limitations and contraindications which need to be considered in the selection of the type of imaging used. In brief, presence of significant calcification reduces the accuracy of CDUS and CTA. Multi-segment disease and oedema also reduce the imaging capability of CDUS. Imaging requiring contrast agents including MRA, CTA, and DSA are contraindicated where there is allergy to the contrast agent or there is significant risk of nephrotoxicity. MRA is also contraindicated in those patients with cardiac pacemakers, and some other implants and in claustrophobic patients without sedation.

Geographically remote people

The panel agreed that while a range of imaging services may be available in metropolitan and regional areas, this access is likely to be very limited in geographically remote areas. In such situations the importance of well-established clinical referral pathways to support timely access to services is paramount.

Aboriginal and Torres Strait Islander people

The panel considered that this recommendation was appropriate for Aboriginal and Torres Strait Islander people. Consistent with populations in remote geographical areas, the importance of established referral pathways developed in conjunction with Community-based Aboriginal Health and Medical Services and where the care provision is supported by an Aboriginal Health Worker, is integral to optimising patient outcomes. In addition, the reader is referred to considerations for Aboriginal and Torres Strait Islander people for recommendations 1 and 2.

For detailed implementation, monitoring and research considerations see eTable C10 in Supplementary Material.

Question six (recommendations 11–15)

What are the aims and methods of revascularisation and onward management in a person with diabetes, foot ulceration, and PAD?

Recommendation 11

When performing revascularisation in a patient with a diabetes-related foot ulcer, aim to restore direct blood flow to at least one of the foot arteries, preferably the artery that supplies the anatomical region of the ulcer. After the procedure, evaluate its effectiveness with an objective measurement of perfusion. (Strong; low).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel was in agreement with the IWGDF regarding the strength of the recommendation (strong) based on the balance of effects favouring revascularisation over no intervention for improving tissue perfusion and DFU healing. The panel also agreed with the IWGDF on the quality of the available evidence (low) due to lack of reporting of included study populations, inconsistent application of interventions and the poor control of potential confounders.

The panel agreed that the intervention is applicable to the Australian context with the majority of Australian patients preferring revascularisation and valuing DFU healing and limb salvage over other outcomes. The panel also agreed that there were no policy or legislative constraints on implementation of this recommendation, and that there is adequate expertise and equipment available in health care settings where patients typically access this care.

Implementation considerations General considerations

While the most effective approach to revascularisation remains a point of contention, the panel agreed with the IWGDF that direct revascularisation, where there is restoration of flow to the anatomical area in which the ulcer is located, will theoretically be more effective than an indirect technique. The panel also agreed that in the presence of end-stage renal disease revascularisation needs to be carefully considered due to high rates of complications, a 5 year mortality rate of up to 91% and moderate limb salvages rates (65–70%) for those surviving to 1 year [21]. The panel agreed with the IWGDF that, in the presence of extensive infection, therapy should be implemented to control the infection prior to undertaking a revascularisation procedure and subsequent restoration of perfusion should be undertaken within a few days of stabilisation of the patient [21].

Geographically remote people

The panel agreed that this recommendation is applicable to people living in geographically remote areas. The panel noted that, for these patients, rapid referral pathways are required to treatment centres offering revascularisation procedures and that access to appropriate follow-up assessments and care needs to be established as part of the management model in conjunction with involved health care providers. Options to support health practitioners in remote areas with appropriate expertise via telehealth and other forms of remote monitoring should be considered.

Aboriginal and Torres Strait Islander people

The panel considered this recommendation to be applicable to Aboriginal and Torres Strait Islander people. Consistent with recommendation 6, the panel agreed on the importance of explaining the need for, and nature of, any further vascular intervention or surgical intervention including the expected timeframes for, and location of, related hospitalisation and longer-term post-operative care with the patient and their family using a professional interpreter when required. Furthermore, established referral pathways, as well as appropriate, culturally safe follow-up care, are required for Aboriginal and Torres Strait Islander people in all geographical locations. These should be developed in conjunction with Community-based Aboriginal Health and Medical Services where the care access and provision is supported by an Aboriginal Health Worker and professional interpreter (where required) to optimise patient outcomes.

For detailed implementation, monitoring and research considerations see eTable C11 in Supplementary Material.

Recommendation 12

As evidence is inadequate to establish whether an endovascular, open, or hybrid revascularisation technique is superior, make decisions based on individual factors, such as morphological distribution of PAD, availability of autogenous vein, patient co-morbidities, and local expertise. (Strong; low).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

Review of the literature reporting DFU healing and limb salvage outcomes following endovascular and open techniques show these to be similar. However there is a lack of comparative studies evaluating endovascular, open or hybrid techniques in people with diabetes. The panel therefore agreed with the IWGDF on the strength of recommendation (strong) based on a low level of quality of available evidence, and the need for centres treating people with DFU to be able to provide a range of surgical treatment options.

The panel agreed that there would probably be no important uncertainty in relation to the majority of Australian patients preferring the intervention and valuing DFU healing over other outcomes. The panel considered that this recommendation was applicable to the Australian context, that there are no policy or legislative constraints on implementation of this recommendation, and, that there is adequate expertise and equipment available in health care settings where patients typically access this care.

Implementation considerations General considerations

The panel agreed with the IWGDF that the complex nature of diabetes-related PAD, supports the patient-specific approach to selection of revascularisation techniques.

Geographically remote people

This recommendation is applicable to people in geographically remote areas, however, the panel agreed that access to expertise may be variable in some locations and that considerations for this subgroup are consistent with those for recommendation 11.

Aboriginal and Torres Strait Islander people

The panel considered that this recommendation was appropriate for Aboriginal and Torres Strait Islander people and considerations for this subgroup are the same as for recommendation 11.

For detailed implementation, monitoring and research considerations see eTable C12 in Supplementary Material.

Recommendation 13

Any centre treating patients with a diabetes-related foot ulcer should have expertise in, and/or rapid access to facilities necessary to diagnose and treat, PAD, including both endovascular techniques and bypass surgery. (Strong; low).

Decision: Adapted.

Rationale: The panel agreed with the judgements of the IWGDF in relation to the acceptability of the recommendation. The panel decided to adapt this recommendation based on the panel having a difference in judgement of the applicability, specifically in relation to the feasibility of the recommendation in the Australian context (Table 1). Therefore the wording changes to original IWGDF included the addition of ‘and/or’.

Summary justification

The panel agreed with the strength of the recommendation (strong) and the low quality of the available evidence. As per recommendation 12, the panel noted the complex nature of patients presenting with PAD and DFU requiring the availability of a range of surgical treatment options. The panel also agreed that the need for urgent medical intervention particularly in the presence of infection, as well as the short optimal timeframe for revascularisation supports the need for rapid access to diagnostic and treatment services.

The panel agreed that there would probably be no important uncertainty in relation to the majority of Australian patients preferring the intervention and valuing DFU healing over other outcomes. The panel were unsure that having expertise in, and rapid access to, facilities necessary to diagnose and treat PAD including both endovascular techniques and bypass surgery in any centre treating DFU was feasible in the Australian context due to the geographical isolation of many parts of the country. The detailed justifications from our full assessment are provided below.

Detailed justifications

Problem: PAD is estimated to be present in up to 50% of DFU and to be an independent risk factor in their development [10, 11]. The panel agreed that DFU and ischaemia are associated with increased risk of amputation and delay in revascularisation is associated with poorer outcomes. This supports the need for centres treating DFU to have expertise in non-invasive diagnosis of PAD and, at minimum, rapid access to facilities necessary to treat PAD including access to both endovascular and bypass surgery.

Desirable effects

The panel agreed with the IWGDF that that there was a large anticipated benefit of revascularisation over conservative care based on a limb salvage rate at 1 year of 82% following revascularisation versus 50–54% in patients deemed unsuitable for revascularisation and receiving conservative care [21].

Undesirable effects

The panel agreed with the IWGDF that the available evidence supported that the difference in undesirable effects associated with revascularisation was small. This was based on the available evidence showing improved healing and limb salvage outcomes at 1 year following revascularization. Specifically, higher amputation rates (approximately 50%) associated with conservative care in those with DFU and ischaemia at 1 year follow up have been demonstrated compared to those undergoing revascularisation (approximately 18%) at 1 year follow up [21, 50, 51].

Quality (or certainty) of evidence

The panel agreed with the IWGDF that the quality of evidence was low. This was based on observational and restrospective data demonstrating shorter time periods to revascularisation of between 2 and 8 weeks were associated with higher probability of DFU healing and lower likelihood of limb loss [47, 52].

Values

The panel agreed with the IWGDF that there was probably no important uncertainty or variability in the extent to which patients valued the outcome measures used to compare the intervention (revascularisation) versus conservative care, such as healing and amputation.

Balance of effects

Although there is a low level of evidence, the panel agreed with the IWGDF that the recommendation was strong based on large desirable effects on healing outcomes and limb salvage rates and trivial undesirable effects on adverse events with vascular intervention in patients with ischaemic DFU.

Acceptability

The panel agreed with the IWGDF that revascularisation with either endovascular techniques and/or bypass surgery would be acceptable to the majority of patients and providers in most healthcare settings that typically provide such services in Australia. This was on the basis that the panel considered that most Australian patients and providers would accept the evidence that the balance of effects was in favour of revascularisation over conservative care in the presence of DFU with ischaemia.

Feasiblity

The panel members were unsure if they agreed with the IWGDF on the feasibility of this recommendation in the Australian context. The basis of the uncertainty related to the recommendation that all centres treating DFU have expertise in, and rapid access to facilities necessary to diagnose and treat, PAD, including both endovascular techniques and bypass surgery. The expert opinion of the panel was that such expertise and facilities were not available at all centres treating DFU in Australia. The panel recognised that high service costs and low target populations challenge viability of health care provision in regional and remote areas, and, that this applied to the specialised services and facilities required for advanced diagnosis and surgical interventions for PAD. The panel agreed that in these circumstances, in addition to ensuring availability of appropriate bedside vascular testing onsite, establishing formal pathways to ensure rapid access to such facilities and expertise was appropriate for centres treating DFU in regional and rural Australia.

Implementation considerations General considerations

The panel agreed with the IWGDF regarding the need for rapid access to further vascular imaging and revascularisation services based on evidence of improved outcomes with prompt revascularisation intervention [47, 52, 53]. Given the lack of evidence to support one form of revascularisation technique over others (i.e. open versus endovascular), the panel agreed with the IWGDF that both techniques should be available [53]. As per recommendation 12, given the complex, multi-system nature of diabetes and the specific complications this causes the panel agreed the patient-specific approach to choice of revascularisation technique is appropriate. Due to the variable nature of the extent of health care services available throughout rural and regional Australia and, related to this, the differing availability of services to provide post-operative follow-up care, the panel noted the need for development of local pathways specific to the needs of individual DFU centres. The panel also identified that, as per recommendations 11 and 12, telehealth and other forms of remote monitoring provide mechanisms to support health practitioners, referral pathways and care models in rural and remote areas. Facilitation of rapid referral and provision of appropriate expertise via these mechanisms should be integrated into the development of local referral pathways, and as part of the management model in conjunction with involved health care providers. As alternatives to providing onsite care in geographical regions with small populations, the panel agreed these resources should be prioritised for future government and health services funding to support a nation-wide approach to provision of optimal DFU care.

Geographically remote people

The reader is referred to the panel’s advice for recommendations 11 and 12.

Aboriginal and Torres Strait Islander people

In terms of considerations for Aboriginal and Torres Strait Islander people, the panel’s advice is consistent with recommendation 11.

Monitoring considerations

The panel agreed formal monitoring systems to be able to collect, monitor and analyse revascularisation and DFU healing outcomes in accordance with national based High Risk Foot Service database monitoring systems and datasets where applicable to this recommendation [54,55,56]. This is particularly important to monitor outcomes for patients being referred from rural and remote areas, to include effectiveness of referral processes and wait times.

Future research considerations

Existing data demonstrates health disparities for all Australians living in rural and remote areas [57]. Further prospective research assessing comparative outcomes for patients with DFU in rural and regional Australia is required to better inform service delivery models to support patients in these areas. In addition, increasing availability of health technology offers the opportunity to investigate methods to improve access to diabetes-related foot care for people living in rural and remote areas through remote monitoring programs supported by local community health workers, and should be a focus for populations where access to care is restricted and there is high risk of amputation. This is particularly relevant to Aboriginal and Torres Strait Islander Communities with Aboriginal and Torres Strait Islander people comprising up to 91% of those undergoing amputation in rural and remote Australia [20, 58, 59].

Recommendation 14

Ensure that after a revascularisation procedure in a patient with a diabetes-related foot ulcer, the patient is treated by a multidisciplinary team as part of a comprehensive care plan. (Strong; low).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel concurred with the IWGDF on the strength of this recommendation (strong) and the low quality of available evidence. The panel agreed that the intervention is applicable to the Australian context with the majority of Australian patients preferring DFU healing through use of patient-specific multidisciplinary management over other outcomes. The panel agreed that there were no policy or legislative constraints for implementation of this recommendation, and, that there is adequate expertise and equipment available in health care settings in the majority of locations where patients typically access this care.

Implementation considerations General considerations

The IWGDF Practical guidelines on prevention and management of diabetes-related foot disease reflect the multifaceted nature of DFU development and management, and highlight that the restoration of perfusion is only one aspect of a good standard of DFU care [25]. Other aspects of care should include effective pressure offloading and protection of the ulcer, ongoing wound debridement, appropriate management of infection, glycaemic control, and other comorbidities, and patient education, remain essential components of successful management [60].

Geographically remote people

The panel agreed that this recommendation was applicable to geographically remote people and the panel’s advice is consistent with recommendations 11 and 12.

Aboriginal and Torres Strait Islander people

The panel agreed that this recommendation was applicable to Aboriginal and Torres Strait Islander people and refer the reader to considerations noted for this subgroup in recommendation 11.

For detailed implementation, monitoring and research considerations see eTable C14 in Supplementary Material.

Recommendation 15

Urgently assess and treat patients with signs or symptoms of PAD and a diabetes-related foot infection, as they are at particularly high risk for major limb amputation. (Strong; moderate).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel was in agreement with the IWGDF that this was a strong recommendation with moderate quality of available evidence. There is a limb loss rate of up to 44% at 12 months for patients with diabetes and foot infection [11]. In Australia, in patients with diabetes-related foot infections, Aboriginal and Torres Strait Islander people have been shown to have a four to six-fold increase in risk of amputation compared to non-Indigenous patients [61]. The panel agreed with the IWGDF that revascularisation should take place promptly following control of significant infection and patient stabilisation and that any further procedures required to restore foot function should be considered after successful revascularisation. The panel agreed that the intervention is applicable to the Australian context with the majority of Australian patients preferring DFU healing and reduction in risk of limb loss. The panel agreed that there were no policy or legislative constraints on implementation of this recommendation. The panel also agreed that there is adequate expertise and equipment available in health care settings in the majority of locations where patients typically access this care.

Implementation considerations General considerations

The panel agreed with the IWGDF that revascularisation should take place promptly following control of significant infection and patient stabilisation and that any further procedures required to restore foot function should be considered after successful revascularisation.

Geographically remote people

In terms of considerations to use this recommendation in geographically remote people, the panel’s advice is consistent with recommendations 11 and 12.

Aboriginal and Torres Strait Islander people

In terms of considerations for Aboriginal and Torres Strait Islander people, the panel’s advice is consistent with recommendation 11.

For detailed implementation, monitoring and research considerations see eTable C15 in Supplementary Material.

Question seven (recommendation 16)

In a patient with a diabetes-related foot ulcer and PAD, are there any circumstances in which revascularisation should not be performed?

Recommendation 16

Avoid revascularisation in patients in whom, from the patient’s perspective, the risk-benefit ratio for the probability of success of the procedure is unfavourable. (Strong; low).

Decision: Adopted.

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel agreed with the IWGDF on the strength of the recommendation (strong) and the low quality of available evidence. The panel also agreed with the IWGDF that, from a patient perspective, a revascularisation procedure may represent an unacceptable risk due to the heightened possibility of perioperative mortality, or due to a limited chance of a favourable surgical outcome.

The panel also agreed that this recommendation is applicable to the Australian context, with the majority of Australian patients preferring avoidance of revascularisation where the risk: benefit ratio is likely to be unfavourable over other management outcomes. The panel agreed that there were no policy or legislative constraints on implementation of this recommendation in Australia. The panel also agreed that there is adequate expertise and equipment in health care settings where the majority of patients typically access DFU care to support implementation of this recommendation.

Implementation considerations General considerations

The panel agreed with the IWGDF that a decision to choose conservative care over revascularisation should be discussed with the patient in conjunction with a multidisciplinary care team including a vascular surgeon. Evidence of a 50% healing rate for ischaemic DFU in patients with diabetes unsuitable for revascularisation should also be considered in determining choice of care [50, 51]. Further to this, the panel agreed with the IWGDF that, where a patient was considered to be unsuitable for revascularisation, other experimental techniques including venous arterialisation or intermittent pneumatic compression therapy may offer potential alternative treatments, although their effectiveness has not yet been substantiated.

Geographically remote people

The panel agreed that this recommendation was applicable to people in geographically remote locations. Ensuring ease of access to regular ongoing care in the case of conservative treatment should be a priority when developing individual management plans. Use of remote support via telehealth to support local delivery of care both post revascularisation and in patients that are unsuitable for revascularisation should be considered in areas where there are limited local health services.

Aboriginal and Torres Strait Islander people

The panel agreed this recommendation was applicable to Aboriginal and Torres Strait Islander people. The panel agreed involvement of Aboriginal and Torres Strait Islander Health Workers and Aboriginal Health and Medical Services and health care providers in discussions relating to vascular intervention and conservative care and subsequent care provision is essential for optimising patient outcomes.

For detailed implementation, monitoring and research considerations see eTable C16 in Supplementary Material.

Question eight (recommendation 17)

In patients with diabetes, foot ulceration, and PAD, is it possible to reduce the risk of future cardiovascular events?

Provide intensive cardiovascular risk management for any patient with diabetes and an ischaemic foot ulcer, including support for cessation of smoking, treatment of hypertension, control of glycaemia, and treatment with a statin drug as well as low-dose clopidogrel or aspirin. (Strong; low)

Decision: Adopted

Rationale: The panel decided to adopt this recommendation. The panel agreed with the judgements of the IWGDF and considered this recommendation to be acceptable and applicable in the Australian context (Table 1).

Summary justification

The panel concurred with the IWGDF on the strength (strong) of this recommedation and the low quality of available evidence. The panel also agreed that this recommendation is applicable to the Australian context with the majority of Australian patients likely to be in favour of the intervention. The panel agreed that there were no policy or legislative constraints on implementation of this recommendation in Australia, and that there is adequate expertise and equipment in health care settings where the majority of patients typically access DFU care to support implementation of this recommendation.

Implementation considerations General considerations

The panel agreed with the IWGDF that all patients with PAD and DFU should be supported to stop smoking, maintain current guideline recommendations for glycaemic and blood pressure control and to take statin and antiplatelet therapy [60]. The panel agreed with the IWGDF that there is no clear evidence in favour of one antiplatelet agent over another, although the panel also agreed that their use individually and in combination is likely to reduce major lower limb events and contribute to a reduction in 5 year mortality [62, 63].

Geographically remote people

Relative geographical isolation may reduce access to available support and health education and promotion services required for successful risk factor modification. Referral to appropriate remote support through telehealth and online services should be a priority for patients in these areas.

Aboriginal and Torres Strait Islander people

This recommendation is applicable to Aboriginal and Torres Strait Islander people. The panel noted the high prevalence of risk factors for PAD and cardiovascular disease including smoking and hypertension in this population. This highlights the need for establishment of appropriate care referral pathways and care provision to be co-ordinated through Aboriginal Health and Medical Services and for care provision to be supported by an Aboriginal Health Worker to optimise patient outcomes. Further considerations are consistent with those provided for this subgroup in recommendation 11.

For detailed implementation, monitoring and research considerations see eTable C17 in Supplementary Material.