A.

IDENTIFYING THE AT-RISK FOOT

The IWGDF risk stratification system referred to throughout is detailed in Table 5.

Q1. In people with diabetes, is structured annual screening for risk factors of foot ulceration, compared with less frequent or unstructured screening, effective for preventing a first-ever or recurrent DFU?

Table 5 The IWGDF Risk Stratification System* Recommendation 1

Examine a person with diabetes at very low risk of foot ulceration (IWGDF risk 0) annually for signs or symptoms of loss of protective sensation and peripheral artery disease, to determine if they are at increased risk for foot ulceration. (GRADE strength of recommendation: Strong; Quality of evidence: Low).

Decision: Adapt.

Rationale

The panel decided to adapt this original IWGDF recommendation, based on having a differing judgement to the IWGDF on the quality of evidence rating. Therefore, we downgraded the quality of evidence from high to low (Table 2).

Summary of justification to adapt

Although the panel agreed with the IWGDF that the strength of this recommendation is strong, we disagreed that the quality of evidence supporting this is high [8]. The reason for our divergent judgement is that in our assessment while evidence exists supporting loss of protective sensation and PAD as risk factors for foot ulceration [16], no direct evidence, or a very low quality of supporting evidence, was available affirming the degree to which screening for these risk factors translates into prevention of DFU [8]. Furthermore, in our expert opinion, there are several scenarios whereby detection of ulcer risk upon screening might not result in DFU prevention, such as non-adherence to ulcer prevention strategies or deterioration in ulcer risk status between screenings. The panel therefore deemed that further research is required before a quality of evidence rating above low can be considered for this recommendation.

Otherwise, on all other EtD criteria judgements that led to the strength of recommendation rating, the panel were closely aligned with the IWGDF. There was strong agreement that identification of foot ulcer risk was, on face value and in our expert opinion, highly important for appropriate and targeted DFU preventative treatment and most probably offered at least moderate additional desirable effects (benefit) compared with not examining for foot ulcer risk. The panel, including consumer representatives, acknowledged that fast and effective approaches to identifying DFU risk were also of great value to persons with diabetes, and essential to receiving the right support and care. Conversely, undesirable effects from the possibility of the individual sustaining harm from screening was considered very unlikely, or trivial at best compared to not screening, given its non-invasive, inexpensive, and fast administration. Thus, the balance of effects favoured screening for increased risk compared to not screening, based on the difference between at least moderate likely desirable effects and trivial likely undesirable effects.

The panel also agreed that costs on a societal level, for example, across large publicly funded health services, may be a challenge to address. Arguably, the monetary costs of screening, however, are probably significantly outweighed by its benefits, although empirical data to inform this debate is not currently available. Optimal time periods for re-screening also need to be determined when considering costs versus benefits. The panel agreed that yearly screenings were likely to be acceptable and feasible for most people with diabetes at very low risk of DFU. Thus, overall, we agree with the IWGDF that the strength of the recommendation is strong, based on a clear balance of effects, acceptability and feasibility for screening for increased risk compared to not screening.

B.

REGULARLY INSPECTING AND EXAMINING THE AT-RISK FOOT

The IWGDF risk stratification system referred to throughout is detailed in Table 5.

Q2. In people with diabetes at risk for foot ulceration, what are the risk factors that should be screened for, for preventing a first-ever or recurrent DFU?

Recommendation 2

Screen a person with diabetes at risk of foot ulceration (IWGDF risk 1–3) for: a history of foot ulceration or lower-extremity amputation; diagnosis of end-stage renal disease; presence or progression of foot deformity; limited joint mobility; abundant callus; and any pre-ulcerative sign on the foot. Repeat this screening once every 6–12 months for those classified as IWGDF risk 1, once every 3–6 months for IWGDF risk 2, and once every 1–3 months for IWGDF risk 3. (Strong; Low).

Decision: Adapt.

Rationale

The panel decided to adapt this recommendation as we had differing judgements for the quality of evidence rating. Therefore, we downgraded the quality of evidence rating from high to low (Table 2).

Summary of justification to adapt

As for recommendation 1, the panel agreed with the IWGDF that the strength of recommendation 2 is also strong, however disagreed that the quality of evidence is high with similar justification [8]. While the key factors which are predictive of re-ulceration have a high quality of supporting evidence [1, 16, 17, 37], the degree to which screening for these factors is effective for prevention of DFU, and the optimal intervals for screening, have no evidence to our knowledge, or a very low quality of supporting evidence. The panel therefore also deemed that further research is required before a collective quality of evidence rating above low can be considered for this recommendation as well.

Otherwise, again the panel agreed with all other EtD criteria judgements that led to a strong strength of recommendation, including supporting the judgement that timely and targeted screening of people at risk of DFU, for the aforementioned risk factors, is pertinent for good care and offered at least a moderate additional desirable effect compared to not screening. It makes good intuitive sense that more frequent screening may result in early identification of risk factors, earlier intervention and, based on expert opinion, better prognosis in people who are already at risk. We agree that customised preventative treatment following screening is likely to outweigh possible harms, if treatment is provided by a suitably trained health care professional following evidence-based practice. The panel note that such screening may be anxiety provoking for some people, however agreed that it conversely offers additional opportunity for education and psychological support that individuals may value in addressing fears around developing a DFU and thus trivial undesirable effects. Therefore, similarly to recommendation 1, the balance of effects favoured screening for these risk factors compared with not screening, and screening was deemed acceptable, inexpensive, and thus feasible to most individuals. Although, costs at a societal level may be challenging to assess with the available evidence. Optimal time periods for re-screening also need to be determined when considering costs versus benefits. Taken together, the panel agrees that the strength of recommendation is strong for foot screening according to recommendations 1 and 2.

Considerations for the Australian context: recommendations 1 and 2

We have summarised suggestions for health professionals to consider for implementing screening in Table 6 (for recommendation 1) and Table 7 (for recommendation 2), and otherwise we refer readers to the IWGDF Prevention Guidelines [8] for full details on screening considerations (pp. 3–5). It is the panel’s view that these screening tests and protocols are already widely used in current practice and there are few additional considerations for translation into the Australian context. Given the geographical size and diversity of Australia, and the sometimes limited availability of health services or services with sufficient training (see glossary for definition), some individuals may not be able to access timely screening as recommended. For example, Aboriginal and Torres Strait Islander populations in rural and remote areas of Australia may not be able to access such screening routinely due to a lack of services or factors such as seasonal movement. Of note, screening should be performed by an adequately trained heath care professional (such as a general practitioner, podiatrist, diabetes educator), which may add an additional barrier to its availability. However, the panel considers that to adequately train health professionals to competently perform foot risk screening is not a complex activity and there are a number of training programs or tools available to address this activity (such as the Indigenous Diabetic Foot Program [49] and the Foot Forward Train the Trainer Program [50]). Care should be taken to monitor a person’s risk status over time and adjust the screening interval according to any changes in risk status (see Table 5). For example, risk status would be increased if foot complications occurred. Therefore, due to potential limited access, movement (e.g. cultural practices), greater severity of diabetes, and greater risk of complications of some Aboriginal and Torres Strait Islander people, health professionals may also consider opportunistic screening and/or more frequent screening (e.g. every 6 months).

C.

INSTRUCTIONS ON FOOT SELF-CARE

Table 6 Summary of IWGDF screening suggestions for Recommendation 1*Table 7 Summary of IWGDF screening suggestions for Recommendation 2*

‘Foot self-care’ and ‘foot self-management’ (see glossary for definitions) are two closely related interventions that both aim to reduce the risk of DFU and its associated complications. Foot self-care interventions (e.g. foot inspection, using emollients to lubricate dry skin, footwear inspection, etc) can be performed independently by the patient at home, whereas foot self-management involves more advanced assistive interventions, such as home monitoring systems (e.g. foot skin temperatures), lifestyle interventions, and telehealth [8, 51, 52]. The uptake of education and tasks relevant to foot self-care and foot self-management will be dependent on the individual’s unique physical and psychosocial circumstances and capacity to meet their particular requirements. Therefore, patients are encouraged to seek further support, or supports be arranged with the appropriate consents, if a patient is unable to perform these tasks themselves.

Q3. In people with diabetes at risk for foot ulceration, is foot self-care compared to no self-care, effective for preventing a first-ever or recurrent DFU?

Recommendation 3

Instruct a person with diabetes who is at risk of foot ulceration (IWGDF risk 1–3) to protect their feet by not walking barefoot, in socks without shoes, or in thin-soled slippers, whether indoors or outdoors. (Strong; Low).

Decision: Adopt.

Rationale

The panel adopted this recommendation as there was full agreement with the IWGDF regarding the strength of the recommendation and quality of evidence ratings and its applicability in the Australian context (Table 2).

Summary of justification to adopt

The panel agreed with the IWGDF that there is low-quality supporting evidence for this recommendation. However, given that walking unprotected could be harmful and result in foot ulceration or external/mechanical trauma to the foot [8, 26, 53, 54], there was strong agreement with the IWGDF that education pertaining to the protection of the feet is a highly important DFU prevention strategy [8]. While some patients may prefer not to adhere to this recommendation, particularly when inside the home, the panel suggests that the benefits outweigh any potential harms or burden to the patient. On all other points of assessment for recommendation 3, the panel were closely aligned to the rationale of the IWGDF. The panel, including consumer representatives, agreed that education in how to protect the feet is likely to be acceptable and feasible for most people with diabetes.

Protecting the feet from high mechanical stress and external physical trauma is essential for reducing the risk of ulceration in a person with diabetes at risk of foot ulceration [8, 55]. This is also an important consideration in the Australian context; walking barefoot (e.g. on the beach) or with open type footwear is common, particularly in parts of Australia with hot climates. While this recommendation focuses on the protection of the feet both indoors or outdoors by not walking barefoot, in socks without shoes, or in thin-soled slippers, the panel agreed with the IWGDF that the use of any open type footwear increases the risk for direct damage to the skin by a foreign object [8, 55], but may also increase the risk of sunburn to the feet in the Australian context. While there is little empirical evidence to support the avoidance of open type of footwear in reducing the risk of ulceration, the panel suggests that closed-toe footwear is recommended as it protects the feet from mechanical impact, as well as reduces the risk of trauma and the collection of foreign objects. In exceptional circumstances (e.g. if the patient refuses to wear closed-toe footwear), sandals that can be properly fastened and have plantar pressure offloading ability that has been verified in each individual case, may be considered in preference to the patient walking barefoot, in socks, or in slip-on footwear. Although there is no evidence to support that wearing socks when in footwear reduces friction/shearing forces, based on expert opinion, the panel recommends that socks should be worn as this may reduce the risk of blistering, rubbing, or ulceration [55]. In addition, wearing clean socks when in shoes may also reduce the incidence of skin and nail infections (e.g. fungal infections) [56].

Recommendation 4

Instruct, and after that encourage and remind, a person with diabetes who is at risk of foot ulceration (IWGDF risk 1–3) to: inspect daily the entire surface of both feet and the inside of the shoes that will be worn; wash the feet daily (with careful drying, particularly between the toes); use emollients to lubricate dry skin; cut toe nails straight across; and, avoid using chemical agents or plasters or any other technique to remove callus or corns. (Strong; Low).

Decision: Adopt.

Rationale

The panel adopted this recommendation as there was full agreement with the IWGDF regarding the strength of the recommendation and quality of evidence ratings and its applicability in the Australian context (Table 2).

Summary of justification to adopt

The panel agreed with the IWGDF that although there is low-quality supporting evidence for this recommendation, the strength of the recommendation should be considered ‘strong’ based on the balance of effects favouring foot self-care for the prevention of a first-ever or recurrent DFU (by detecting early signs of DFU and contributing to basic foot hygiene) [8]. On all other points of assessment for recommendation 4, the panel were closely aligned to the rationale of the IWGDF. The panel, including consumer representatives, agreed that education in performing good foot self-care practices is likely to be acceptable and feasible for most people with diabetes.

D.

PROVIDING STRUCTURED EDUCATION ABOUT FOOT SELF-CARE

Q4. In people with diabetes at risk of foot ulceration, is providing structured education about foot specific self-care compared to not providing it, effective for preventing a first-ever or recurrent DFU?

Recommendation 5

Provide structured education to a person with diabetes who is at risk of foot ulceration (IWGDF risk 1–3) about appropriate foot self-care for preventing a foot ulcer. (Strong; Low).

Decision: Adopt.

Rationale

The panel adopted this recommendation as there was full agreement with the IWGDF regarding the strength of the recommendation and quality of evidence ratings and its applicability in the Australian context (Table 2).

Summary of justification to adopt

When considering the balance of effects favouring structured foot self-care education over no education for the prevention of a first-ever or recurrent DFU, the panel were in agreement with the IWGDF that although there is low-quality supporting evidence for this recommendation, the strength of the recommendation should be considered ‘strong’ [8]. Despite education potentially resulting in a fear of complications for the patient, there was strong agreement with the IWGDF that structured education pertaining to: foot ulcers and their consequences; positive foot self-care behaviours; wearing protective footwear; undergoing regular foot checks; performing proper foot hygiene; and seeking professional help in a timely manner when a foot problem is discovered are all important DFU prevention strategies [8]. Providing structured education may also serve as a forum for patients to clarify any questions or uncertainties they have regarding their foot health management. On all other points of assessment for recommendation 5, the panel were closely aligned to the rationale of the IWGDF. Given the potential consequences and clinical sequelae of DFU, the panel and consumer representatives agreed that receiving structured education aimed at preventing DFU is likely to be acceptable and feasible for most people with diabetes at risk of ulceration.

Considerations for the Australian context: recommendations 3, 4 and 5

Structured education on foot self-care practises is an essential component of foot ulcer prevention in an at-risk person with diabetes [8]. Specific examples of patient education include, but are not limited to, explaining the need for daily inspection of all surfaces of the feet including between the toes, ensuring the patient knows when and how to contact the appropriate health professional if signs of inflammation or pre-ulcerative signs are present or if there is a breach to the skin such as an ulcer, and specific foot practices such as using emollients to lubricate the skin (but not between the toes). Refer to the IWGDF Practical Guidelines [26] for further details. Furthermore, the education provided should be appropriate to the person’s culture, level of health literacy and preferred learning style (e.g. visual, verbal, written, illustrated).

From an Australian perspective, those living in geographically remote locations, where Aboriginal and Torres Strait Islander people account for a higher proportion of this population, may have limited availability of health services and adequately trained health professionals to provide such education. Likewise, these individuals may also have infrequent access or limited ability to attend for medical care to receive this foot care education; all of which may act as potential barriers for implementing these recommendations. However, national programs such as the ‘Foot Forward Train the Trainer Program’ [50] may aid in developing widespread competencies in foot screening, providing appropriate foot self-care education, and appropriate escalation of clinical care.

Performing foot self-care practises is particularly important for those living in rural or remote areas of Australia with hot climates; as this may precipitate perspiration and increased risk of blistering and/or ulceration. And similarly, for dry and dusty environments, people may need to wash their feet more regularly and check for any abrasions, sunburn, or injuries from foreign objects, particularly if people are wearing open type footwear or walking barefoot.

The panel suggest that special considerations may need to be made for the delivery of educational programs for those living in rural or remote areas of Australia. Telehealth services may play an important role in addressing this issue, however, further research into its effectiveness is required [57]. Other examples of delivery may include high-risk foot service teams visiting communities to facilitate education, drop-in foot clinics or education through other multimedia platforms. In both cases, equipment and resources would need to be made available to health care services and patients, which may not always be feasible. It is likely that some services may be better resourced than others to support such programs.

Health disparities between Aboriginal and Torres Strait Islander peoples and non-Indigenous Australians have been well documented [58,59,60,61]. Poorer health outcomes for Aboriginal and Torres Strait Islander populations are in part due to a higher prevalence of chronic diseases such as diabetes, but is further accentuated by geographical isolation [62]. The panel suggest that structured education should be culturally appropriate and address certain provisions for Aboriginal and Torres Strait Islander peoples. To provide some context, Aboriginal and Torres Strait Islander peoples do not just form one group of people, but there are hundreds of discrete groups; all with distinct languages, social structures, cultural and social traditions, important sites and landmarks, and passing on of traditions, beliefs and customs with storytelling [62]. There should be thought and consultation of whether face-to-face, individual or group approaches would be preferred, and whether educational handouts are culturally appropriate. The inclusion of Aboriginal and Torres Strait Islander artwork and/or flags on educational material may assist in promoting culturally sensitive education. The location of education sessions should also be considered. For example, cultural safety of presenting education “on Country” or in an Aboriginal Community Controlled Organisation. Holding sessions outdoors may also be considered, weather permitting [63].

While more Aboriginal and Torres Strait Islander peoples are progressing through schooling (i.e. achieving national minimum standards for literacy and numeracy), completing year 12, and enrolling in university [58], there may still be reduced health literacy among some Aboriginal and Torres Strait Islander communities. Therefore, foot self-care education should not rely on handouts alone. The panel agreed with the IWGDF that structured education should also account for gender differences and align with the patient’s health literacy and personal circumstances [8]. There must also be consideration of language barriers in consultation, especially where English may be a second, third or fourth language. In these situations, a professional interpreter should be considered.

Health professionals are encouraged to have discussions regarding whether there is regular sharing of shoes and socks within the community. The panel suggests that this should be avoided as to reduce spreading of infections (e.g. fungal infections), and to reduce risk of trauma to the feet related to poor shoe fit or excessively worn footwear. Consideration must be given to the financial cost of footwear, and where possible, more affordable suggestions or recommendations should be made. The panel acknowledge that, in some communities, perhaps many communities, people wear shoes infrequently, or not at all, and this may be for cultural reasons. We recommend health professionals adhere to this prevention guideline wherever possible but may also consider other non-conventional treatment options (e.g. supportive thongs). Health professionals should also have an understanding of Aboriginal and Torres Strait Islander cultural practises (e.g. traditional dance will be performed barefoot to be connected to the land). Perhaps education and consultation with family on how to apply dressings to any cuts or wounds on the sole of the feet prior to cultural activities, and cleaning and redressing any wounds afterwards may be considered.

Most importantly, developing partnerships and engaging with local Aboriginal and Torres Strait Islander health care workers, Liaison Officers and/or community members, such as family and Elders, may assist in promoting these recommendations by determining the best approach for providing education and to ensure it is culturally sensitive. This may optimise understanding and in turn the patient’s outcomes.

E.

INSTRUCTIONS ABOUT FOOT SELF-MANAGEMENT

Q5. In people with diabetes at risk for foot ulceration, is foot self-management compared with no self-management, effective for preventing a first-ever or recurrent DFU?

Recommendation 6

Consider instructing a person with diabetes who is at moderate or high risk of foot ulceration (IWGDF risk 2–3) to self-monitor foot skin temperatures once per day to identify any early signs of foot inflammation and help prevent a first or recurrent plantar foot ulcer. The implementation of this recommendation is contingent on validated, user-friendly and affordable systems becoming approved and available in Australia. If the temperature difference is above-threshold between similar regions in the two feet on two consecutive days, instruct the patient to reduce ambulatory activity and consult an adequately trained health care professional for further diagnosis and treatment. (Weak; Moderate).

Decision: Adapt.

Rationale

The panel adapted this recommendation by adding a statement regarding the current lack of availability and approval of this validated, user-friendly technology in Australia (Table 2).

Summary of justification to adapt

The panel agreed with the IWGDF that the strength of the recommendation is ‘weak’ and the quality of evidence is ‘moderate’ based on the findings from four randomised clinical trials [64,65,66,67] and a meta-analysis [52] that support the value of home temperature monitoring and offloading of ‘hot spots’ (i.e. localised areas of inflammation) for the prevention of DFU [8, 52]. The decision not to increase the quality of evidence and strength of recommendation ratings was based on the existing trials having small sample sizes and three of the four trials were conducted in the United States (US); therefore, generalisability outside of the US is unknown. A recent meta-analysis suggested home foot temperature monitoring and reducing of physical activity in response to hot spots halved the risk of foot ulcers in moderate or high risk patients. The significance of findings were however lost in some of the leave one out sensitivity analyses [52].

The panel, including consumer and Aboriginal and Torres Strait Islander representatives, had concerns regarding the acceptability and feasibility of foot temperature monitoring in the Australian context. Currently, there are no validated, user-friendly, and affordable foot skin temperature monitoring devices that have received Therapeutic Goods Administration (TGA) approval in Australia. The TempTouch device (Xilas Medical, San Antonio, TX) was used in all clinical trials [64,65,66,67]. It is appropriately calibrated for skin temperatures and is relatively affordable (~$150 USD). Production of this device has however been discontinued and no other validated, user-friendly devices are currently approved or available in Australia. Other infrared dermal thermometers can be purchased in Australia but have not currently been validated for home foot temperature monitoring. For example, DermaTemp (Exergen Corporation, Watertown, MA) is a commonly used device in High-Risk Foot Services (HRFS), however it is not designed for self-monitoring and is significantly more expensive (>$1000 AUD). Another concern with handheld thermometers, like TempTouch, is that the user has to hold the device at 6 different anatomical sites on the sole of each foot and then record and interpret the temperatures at those sites daily [64,65,66,67]. This requires substantial time commitment from users and the flexibility to carry out this task daily. At least two more user-friendly foot temperature measuring mats have been designed and are in use in the US [51]. Currently, these are not available in Australia and since they were not included in the randomised trials, it is rather uncertain what effect they may have on ulcer prevention. Hence, the implementation of this recommendation is contingent on validated, user-friendly and affordable systems becoming approved and available in Australia.

While the existing trials [64,