Model of Care for the Diabetic Foot

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Model of Care for the Diabetic Foot National Clinical Programme for Diabetes Clinical Strategy and Programme Division 2018 Revision number Document drafted by National Clinical Programme for Diabetes Working Group Approval date October 2011 Document approved by Revision date Responsibility for implementation Responsibility for evaluation and audit National Clinical Programme for Diabetes 1

Index 1.0 Introduction 4 1.1 Purpose of the Model of Care 4 1.2 Principles of the Model of Care 5 1.3 The foot protection team (FPT) and multidisciplinary diabetes foot team (MDfT) 6 1.4 Roles and responsibilities of all health professionals involved in the care of the diabetic foot 8 2.0 Risk Classification and Care Pathway 12 2.1 Aim of diabetic foot screening 12 2.2 Routine foot screening process 12 2.3 Risk categories and surveillance 13 2.4 Care pathway for people with diabetic foot problems 14 2.5 Pathway for referral to vascular services 17 2.5.1 Low risk foot 17 2.5.2 Moderate risk foot 17 2.5.3 High risk foot 17 2.5.4 Active foot disease 17 3.0 Care of the Low Risk Foot 18 3.1 Examination of the Low Risk Foot 18 3.1.1 Foot surveillance 18 3.1.2 Screening 18 3.2 Management of the Low Risk Foot 18 4.0 Care of the Moderate Risk Foot 20 4.1 Examination of the Moderate Risk Foot 20 4.1.1 Foot surveillance 20 4.1.2 Screening 20 4.2 Management of the Moderate Risk Foot 21 5.0 Care of the High Risk Foot 22 5.1 Examination of the High Risk Foot 22 5.1.1 Foot surveillance 22 5.1.2 Screening 22 5.2 Management of the High Risk Foot 23 5.3 Special considerations with the high risk foot 24 5.3.1 The diabetic foot in-remission 24 5.3.2 Diabetic foot care in people with renal disease 24 5.3.3 Preventative care for inpatients at risk of heel ulceration 25 6.0 Care of Patients with Active Foot Disease 26 6.1 Care Pathway for Active Foot Disease 26 6.1.1 Foot surveillance 26 6.1.2 Referral to the MDfT 26 6.1.3 Clinical governance active foot disease 27 6.2 Diabetic Foot Ulceration 29 6.2.1 Examination of diabetic foot ulceration 29 6.2.2 Management of diabetic foot ulceration 29 2

6.3 Charcot Foot 30 6.3.1 Examination of Charcot foot 30 6.3.2 Management of Charcot foot 30 6.4 Diabetic Foot Infection 31 6.4.1 Examination of a foot infection 31 6.4.2 Management of a foot infection 32 6.5 Critical Limb Ischaemia 32 7.0 Implementing the Model of Care for the Diabetic Foot 33 7.1 Serious reportable events 33 7.1.1 Definition of stage 3 and 4 pressure ulcers 33 7.1.2 Reporting requirements 33 7.2 Key performance indicators 34 7.3 Clinical Audit 35 7.4 Implementation plan for the model of care for the diabetic foot 36 Glossary of Acronyms 38 References 39 Appendix 1: Minimum Dataset for Referral to the Foot Protection Team 41 Appendix 2: Diabetes Foot Screening Tool 42 3

1.0 Introduction In this section: 1.1. Purpose of the Model of Care 1.2. Principles of the Model of Care 1.3. Membership of the Foot Protection Team and Multidisciplinary Diabetic Foot Team 1.4. Roles and Responsibilities 1.1 Purpose of the Model of Care Diabetic foot disease is one of the most common, serious, feared and costly complications of diabetes. In Ireland, an individual with diabetes is 22 times more likely to undergo a nontraumatic amputation than an individual without diabetes (1). Ulceration and limb loss represents an enormous burden on individuals, their families and on the health and social care system in general. A major goal of the National Clinical Programme (NCP) for Diabetes is to reduce the number of diabetes related amputations in Ireland. Research consistently shows that significant reductions in amputation rates can occur when foot care services for people with diabetes improve, including the introduction of multidisciplinary teams (2) (3) (4). This Model of Care, which is built on the premise of multidisciplinary teamwork, outlines the principles of a high quality foot care service for people with diabetes. Current international guidelines recommend a comprehensive annual foot examination for all people with diabetes to identify risk status and assign an appropriate foot care pathway (5) (6) (7). With an increasing emphasis on primary-care-based management of type 2 diabetes, general practice is the ideal setting for annual foot screening as part of the patients annual diabetes review. For those with type 1 diabetes, annual foot screening should take place in secondary care. Research indicates that 11% of people with diabetes in Ireland are at high risk of future foot ulceration and 25% are at moderate risk (8). This Model of Care sets out the care pathway for these patients based on ulceration risk-status. It recommends a risk-based tiered level of care with a particular emphasis on the timely, evidence-based and integrated management of active foot disease, with the primary goal of amputation prevention. One of the key performance indicators of the NCP Diabetes is a reduction in the number of diabetes related amputations. Unfortunately, despite the significant advances in diabetes foot care in Ireland in recent years, amputation rates continue to rise (9). The reason for this is likely to be multifactorial including better reporting and the rising prevalence of diabetes. The fact that amputation rates are not decreasing highlights the need for greater effort by the health service on a number of fronts: We need a comprehensive population-wide and primary-care based screening programme We need additional podiatrists in our hospitals and community health organisations We need commitment to multidisciplinary team work, by all disciplines involved in the care of the diabetic foot, with podiatrists as the cornerstone of the multidisciplinary diabetes foot team We need a commitment to track prevalence through investment in a diabetes register and joined up clinical information systems 4

This update to the Model of Care aims to address a number of important issues. It clarifies the roles and responsibilities of the various members of the multidisciplinary team involved in managing people with (or at risk of) foot ulceration, as well as the referral pathways within the team. Among the changes in this update, is the recognition of the particular risks of those with end-stage renal disease and patients with a diabetic foot in-remission. This Model of Care for the diabetic foot is based on evidence from a number of different international guidelines (6) (10) (11) (12). It should be used by all health care professionals involved in the care of the diabetic foot both in the hospital and community. 1.2 Principles of the Model of Care A key feature of this Model of Care is that patients with diabetes get the right foot care, at the right time, by the right team and in the right place. This Model of Care outlines a risk-based tiered level of surveillance (table 2), with a particular emphasis on the timely, evidence-based and integrated management of active foot disease, with the primary goal of amputation prevention. The following set of principles underlie this Model of Care: 1. Each HSE Community Health Organisation (CHO) should have a Foot Protection Team (FPT) based in a local hospital. 2. Each FPT should have a named lead podiatrist, a named lead diabetes consultant and a diabetes nurse specialist as members of this team. 3. Each model 4 hospital should have a multidisciplinary diabetes foot team (MDfT) 4. The MDfT should comprise, at a minimum, a named lead podiatrist, a named lead diabetes consultant, and a diabetes nurse specialist and should have access to the following specialties: a vascular surgeon, a tissue viability nurse, an infectious disease consultant or microbiologist, an orthopaedic surgeon, and an orthotist. Where an MDfT is based in a model 3 hospital, there should be clear referral pathways to a surgeon with an interest in the diabetic foot, infectious disease consultant and orthotist. 5. Referral pathways between community podiatry, the FPT and the MDfT should be developed and agreed locally. 6. Patients with newly diagnosed type 2 diabetes should have initial foot screening and risk classification within general practice 7. Each patient with uncomplicated type 2 diabetes that is classified as low risk should have their feet examined on an annual basis in general practice 8. Each patient with complicated type 2 diabetes that is classified as low risk should have their feet examined on an annual basis in secondary care by the diabetes specialist team. 9. Each patient with type 2 diabetes that is classified as moderate risk should be reviewed annually by a community podiatrist. If they have complicated type 2 diabetes and attend secondary care they will be reviewed by the community podiatrist or FPT in the hospital. 10. Each patient that is classified as high risk should be reviewed at least 6-monthly by the FPT in the hospital. 11. All patients with type 1 diabetes should have initial and annual foot screening in secondary care. 12. Patients with active foot disease should be referred to the MDfT in a model 3 or model 4 hospital within 24 hours (this applies to both inpatients and outpatients). 13. Patients with active foot disease that have been referred to the MDfT should be reviewed within 24 hours or the next working day. 14. Patients with active foot disease that have been referred to the MDfT, should be discharged back to the referring FPT once fully healed. 5

1.3 The foot protection team (FPT) and multidisciplinary diabetes foot team (MDfT) Diabetes foot care involves a wide range of professional groups as well as patients and their carers. Central to diabetes foot care, are patients and carers who are required to prevent and self-manage diabetic foot problems in between visits to their healthcare professional. The Foot Protection Team The foot protection team (FPT) is the group of professionals involved in the care of the person with the at-risk foot (i.e. those with a moderate and high risk diabetic foot, including those in-remission). The FPT observe, advise, treat and educate patients and where necessary prescribe footwear and orthoses in order to protect feet from developing active foot disease Membership of the FPT will vary depending on local resources, but ideally should comprise the following health professionals working together with the patient: a) An diabetes consultant b) A podiatrist based in the hospital. c) A diabetes nurse specialist This team will be located in designated hospital sites, and will serve the local catchment area. The FPT works in close collaboration with the patients GP, primary care nurses and community podiatrists. Skills and Competencies (13): The FPT should have the skills and knowledge necessary to: Confirm the presence of neuropathy using, for example, 10g monofilament, sharp/blunt discrimination, vibration perception Assess the severity of peripheral arterial disease Provide treatment of common skin/nail problems Discuss and agree a management plan designed to address the increased risk and to support selfmanagement, including: - provision of specialist education for the patient and their carers - advising on treatments that may be available for neuropathy (including painful neuropathy) - advising on footwear (including the provision of orthoses) - taking steps to reduce the risk imposed by peripheral neuropathy, including debridement of callus - taking steps to reduce the risk imposed by peripheral arterial disease (including referral for further investigation and treatment when appropriate) - taking steps to reduce the risk imposed by deformity or other problems of the foot (including referral for further investigation and treatment when appropriate) - arranging for continued surveillance and treatment as determined by the risk status of the individual 6

The Multidisciplinary Diabetes Foot Team The multidisciplinary diabetes foot team (MDfT) is the multidisciplinary team working together in the model 3 or model 4 hospital looking after patients with active foot disease. Where the MDfT is based in a model 3 hospital, there should be a clear referral pathway to a surgeon with an interest in diabetic foot disease. The MDfT will be referred outpatients and inpatients with active foot disease within 24 hours of presentation for review within a further 24 hours or the next working day. Membership of the MDfT comprises the following specialities working together with the patient: a) An diabetes consultant b) A podiatrist c) A diabetes nurse specialist d) A vascular surgeon e) Tissue viability nurse f) Infectious disease consultant or microbiologist g) An orthopaedic surgeon with an interest in the foot h) An orthotist This team serves the regional hospital network catchment area for active foot disease. In some areas, this team may be required to provide the foot protection service to their local area, The MDfT works in close collaboration with the patients GP, primary care nurses and community podiatrists. Skills and Competencies (13): The MDfT should have the skills, resources and contacts necessary to ensure: Accurate assessment of the factors contributing to the presentation of the ulcer/lesion (including peripheral arterial disease, neuropathy, infection, and relevant medical, personal and social factors) Appropriate management of any infection that is present (including admission to hospital when indicated) Appropriate further investigation (such as X-ray, MRI, arterial imaging) and intervention (including surgical debridement) when indicated Management of the wound-bed to optimise the process of healing (including appropriate debridement and use of surface applications and dressings) Protection of the foot or lesion from trauma when indicated (including formal off-loading with total contact casts, commercial cast walkers or similar appliances) Appropriate management of the acute Charcot foot that the management of other diseases, complications of diabetes and social and personal factors are considered That the patient and their family and carers are aware of the nature and implications of the condition and the principles of management through the provision of information and education, as appropriate Continuing management and review by specialist and non-specialist healthcare professionals, together with the patient and their carers, as appropriate. 7

1.4 Roles and responsibilities of all healthcare professionals involved in the care of the diabetic foot The MDfT clinic is usually led by a diabetes consultant in association with a podiatrist. In reality the most important criteria for leading an MDfT is recognition of the importance of a multidisciplinary approach to decision making and enthusiasm for this challenging area of clinical practice. The goal should be to coordinate care and help the patient navigate through what are often complex care pathways involving many different healthcare professionals. It should be noted that responsibilities outlined below are in addition to local and professional accountability pathways. Diabetic Foot Screeners All podiatrists, practice nurses, GPs, diabetes specialists and other healthcare professionals trained in diabetic foot screening are responsible for assessing the condition of a patient s feet, looking for signs and symptoms of diabetes complications and determining the patient s foot risk status. The diabetic foot screener will take into account all information relating to risk category, taking the appropriate action as indicated in the care pathway in figure 1. This may include referral to the FPT or MDfT for further examination or treatment, with appropriate urgency in line with this Model of Care. Diabetic foot screeners will determine the individual patient s understanding of the risks to their feet and will reinforce the benefits of self-care and monitoring. This includes verbal and written advice to help the individual understand what specific actions they can take to maintain the health of their feet and address any particular problems and risks revealed by the examination. Minimum skillset for diabetic foot screeners (14) : The healthcare professional that performs annual foot screening of those at low risk (which normally occurs in primary care) should have the skills and knowledge necessary to identify, advise and act on: The presence of sensory neuropathy Reduction of arterial supply to the foot Deformities of the foot or other factors that may put it at risk An individual s level of risk to agree plans for future surveillance and supported self-management. Appropriate referrals for expert review of those with increased risk Action to be taken in the event of a new ulcer/lesion Use of footwear and other aspects of foot care that will reduce the risk of a new ulcer/lesion Additional skills are required for those who screen the moderate and high risk foot. These have been outlined previously in the description of the FPT and MDfT. General Practitioner The GP (and the practice nurse) are key to the success of the delivery of this Model of Care for the Diabetic Foot. They are the primary care givers to their patients and are involved in the delivery of their diabetes and non-diabetes care over the lifetime of the patient. The general practitioner works in close collaboration with the FPT and MDfT in the management of patients with diabetes 8

and the importance of good communication between foot-care teams and general practice cannot, be overstated. The Model of Care for the Diabetic Foot asks: - for initial foot screening within general practice of people with newly diagnosed type 2 diabetes - annual foot screening of those with type 2 diabetes that are classified as being at low risk of foot ulceration - ongoing foot review of all patients with diabetes as and when required. Primary Care Nurse Reference to the primary care nurse throughout the document include practice nurses, community registered nurses, public health nurses and nurses working in the elderly care setting. It is recommended that the initial assessment of the feet of patients with diabetes and annual screening of those with a low-risk foot is usually carried out in general practice, by the practice nurse. This involves looking for signs and symptoms of diabetes complications and determining the patient s foot risk status. For some individual cases, this role may fall to the community registered nurse, public health nurse or registered nurses working in residential facilities. In patients with active foot ulceration, the primary care nurse works in close collaboration with the podiatrist in the MDfT in monitoring and dressing the wound, between visits to the podiatrist. Podiatrist A HSE podiatrist should be the central point of contact for any patient with diabetes and foot ulceration. At first contact a complete evaluation will take place to assess the ulcer, identify possible infection, and identify the presence of peripheral arterial disease or neuropathy. Following assessment, the MDfT should agree a comprehensive wound healing management plan with regular re-evaluation, engaging other members of the team as and when necessary to promote recovery and prevent ulcer recurrence. Referral pathways between the MDfT, FPT and community podiatrists should be developed and agreed locally. Diabetes Consultant The MDfT is frequently led by a diabetes consultant in close collaboration with a podiatrist. The diabetes consultant should coordinate a patient s care with the various other members of the team and establish and regularly update a patient s management plan. As well as participating in management of the diabetic foot, the diabetes consultant is also involved in optimising the patient s glycaemic control and reducing the patient s cardiovascular risk. Diabetes Nurse Specialist (DNS) Close liaison with a DNS (either in the hospital or community) is frequently required to attain patient specific glucose targets to ensure timely ulcer healing. Perioperative glucose management is vital to reduce inpatient stay and post-operative wound infection. A specialist nurse should provide education, self-management support and advice with regards to the practical management of blood glucose control, and more complex aspects of diabetes care. Referral to a local self-management education programme should be considered where appropriate. The Diabetes Nurse Specialist (Integrated Care) can provide support and guidance to general practice on the diabetic foot care pathway. 9

Diabetic Foot Surgeon Ulceration in patients with diabetes is frequently complex and multi-factorial and may require surgical debridement and/ or revascularisation. The MDfT should have good links with an appropriate surgeon who has an interest in diabetes foot problems. This could include a vascular, orthopaedic, or plastic surgeon. The surgeon should be involved early in the management of patients with foot ischaemia, deep or complex tissue infection and osteomyelitis. The presence or absence of peripheral arterial disease (PAD) should be established at initial presentation, and if present, this can contribute to ulceration and failure of healing. A specialist vascular surgeon and/or tissue viability clinical nurse specialist should be involved at the point of presentation (either admission to hospital or at an out-patient MDfT service) to guide management and facilitate timely investigation & intervention in people with ulceration and clinical evidence of PAD. Close liaison with radiological specialists in interpreting foot x-rays, MRI scans and invasive and non-invasive vascular studies will aid acute care. To prevent major amputation further endovascular interventions or distal bypass procedures may be required. Tissue Viability Clinical Nurse Specialist A tissue viability clinical nurse specialist (TVCNS) is a health care professional with specialist knowledge and skills in the management and prevention of pressure ulcers and wound healing. A TVCNS should be involved at the point of presentation (either admission to hospital or at an outpatient MDfT service) to guide management and facilitate timely investigation and intervention in people with ulceration and clinical evidence of peripheral arterial disease. The TVCNS plays a central role in the prevention and management of diabetic foot ulcers through their knowledge of the major risk factors, implementation of standardised ulcer prevention and care programmes, metabolic control, early control of infection and improvement of blood supply to the foot. The TVCNS provides education and guidance to other health care professionals on maintaining a patient s good skin condition, repositioning the patient at regular intervals, on dressing products and use of appropriate pressure redistributing equipment (e.g. mattresses and heel protection boots). They also educate the patient regarding foot hygiene, skin care, and appropriate footwear. Microbiologist/ Infectious Diseases Specialist Foot infections in patients with diabetes can be complex and potentially life threatening. Advice should be sought from specialists in microbiology and infectious diseases. Current and locally approved guidelines should be established and used in decision making. Outpatient parenteral antibiotic therapy protocols should be used where appropriate. Empirical antibiotics are frequently required in the acute setting with tailoring of antibiotic when culture and sensitivity data are available. Orthotist Orthotists are health care professionals responsible for the assessment, measurement, design, manufacture, fitting and management of orthoses. Custom accommodative foot orthoses and footwear are recommended to ensure targeted plantar offloading, pressure relief and reduce the risk of re-ulceration in the moderate and high risk diabetic foot. Orthotists have the specialist skills to manufacture footwear, custom made foot orthoses and partial foot prosthesis as well as to modify footwear. 10

Where there is no HSE orthotist available, establishing a good relationship with external third party orthotists is important. Orthotist referrals should be made using the appropriate referral form along with a copy of the Diabetic Foot Screening Tool (appendix 1). Following receipt of the referral, the orthotist assesses the patient and obtains casts and measurements. An individual quotation for the orthoses is forwarded to the local HSE office for funding. Once funding is in place the orthoses are manufactured and fitted. The patient is then reviewed six to eight weeks postdelivery of orthoses to ensure optimum fit and function of orthoses are being attained. Plaster Room Technician The plaster technician should work in collaboration with the MDfT as they have expertise in applying the most appropriate cast to facilitate offloading of high pressure areas in the treatment of diabetic foot ulceration, osteomyelitis and Charcot foot. Casting is not without its risks and hence all plaster technicians must have a heightened awareness of diabetic neuropathy and its potential consequences. Their role includes patient education including advising patients on seeking help if there are any concerns. 11

2.0 Risk Classification and Care Pathway In this section: 2.1 Aim of diabetic foot screening 2.2 Routine foot screening process 2.3 Risk categories and surveillance 2.4 Risk classification and care pathway for people with diabetic foot problems 2.5 Pathway for referral to vascular services 2.1 Aim of diabetic foot screening The aim of foot screening is to determine the patient s risk of ulceration. Based on this assessment the patient should be assigned a risk category, with a care pathway and foot surveillance plan (Figure 1). The foot surveillance plan and care pathway should ensure that all patients with diabetes receive annual (or more frequent) foot screening, foot care, education and review according to their need, and in a setting most appropriate to their need. 2.2 Routine Foot Screening Process Examination of a patient previously classified as low risk or with newly diagnosed diabetes mellitus should include: Foot Inspection o Inspection of skin and nails o Inspection for structural foot deformity o Inspection of any existing foot wounds o Examination of footwear and any orthotic devices. Foot Screening o Peripheral sensory assessment: - Vibration perception testing (128 Hz tuning fork), and - Cutaneous pressure perception testing with a 10g monofilament o Lower limb vascular assessment: - Palpation of foot pulses - Presence or absence of intermittent claudication or rest pain - History of previous amputation Medical History o Patients with diabetic foot ulceration frequently have other co-morbidities. Screening should include a review of comorbidities and thorough metabolic assessment. Good metabolic control and management of comorbidities are a key aspect of helping the patient to heal a foot ulcer. 12

Based on the findings of the screening process, patients should be assigned to a risk category, as detailed in table 1. The subsequent foot management plan is dependent on risk categorisation. 2.3 Risk Categories and Surveillance The risk classification method for basic foot screening involves a history of diabetes related foot complications, a medical history, and an assessment of peripheral sensation, arterial supply and the presence of foot deformity. Based on this assessment, patients are then categorised as being at low, moderate or high risk of diabetic foot ulceration or identified as having active foot disease. Table 1: Risk classification of the diabetic foot (6) Low Risk No Risk Factors Present Moderate risk *Impaired peripheral sensation, or # Impaired circulation, or Deformity High risk *Impaired sensation and # impaired circulation, or *Impaired sensation in combination with significant callus/deformity (based on clinical judgement), or # Impaired circulation in combination with significant callus/deformity (based on clinical judgement) or Chronic kidney disease (Stage 4 or 5) or In-Remission Diabetic foot in-remission, defined as: Previous foot ulcer, or Previous lower limb amputation, or Previous Charcot arthropathy Active Foot Disease Current foot ulcer, or Spreading infection, or Critical limb ischaemia, or Suspicion of an acute Charcot arthropathy, or an unexplained hot, red, swollen foot with or without pain. *Impaired peripheral sensation refers to either impaired cutaneous pressure perception (10g monofilament test) or impaired vibration perception (128 Hz tuning fork test). # Impaired circulation refers to absent foot pulses in either or both feet The screening process should be fully documented using the Diabetes Foot Screening Tool (appendix 1) and the findings should be recorded in the patient s clinical notes. Following risk categorisation, a foot surveillance plan can be developed, as outlined in table 2. The evidence base suggests that an effective care pathway for diabetes foot care will benefit patients and may specifically reduce adverse outcomes such as chronic or recurrent foot ulceration, infection and lower limb amputation. 13

Table 2: Foot Surveillance Plan based on Identified Risk Status Risk Category Surveillance Plan Low risk Level 1: Annual review in general practice* # Ongoing care in general practice Ongoing Self-care Moderate risk Level 2: Annual review by community podiatry Ongoing care in general practice Ongoing self-care High risk Level 3a: 6-monthly review by the FPT Ongoing care by the diabetes specialist team Ongoing care in general practice Ongoing self-care If concern, see within 2-weeks In-remission Level 3b: 3-6 monthly review by the FPT Ongoing care by the diabetes specialist team Ongoing care in general practice Ongoing self-care If concern, see within 1 week. Active foot disease Level 4: Refer within 24 hours for MDfT review within a further 24 hours or the next working day Very frequent review by the MDfT (weekly or as required) Ongoing care by the diabetes specialist team Ongoing care in general practice Ongoing self-care If concern, see within 24 hours *All patients with type 1 diabetes should have annual (or more frequent) foot screening and review in secondary care # Patients with complicated diabetes should have annual (or more frequent) foot screening in secondary care 2.4 Care Pathway for People with Diabetic Foot Problems This integrated care pathway (figure 1) for the diabetic foot is intended to provide a structure and organisation to the foot care needs of patients with diabetes. The key feature is foot care being provided by an appropriate healthcare professional at a frequency appropriate to the patient s needs. The care pathway starts at the point of diagnosis of diabetes and continues indefinitely. It should be flexible to respond to the needs of the patient as developments occur during the course of their disease progression. 14

Routine diabetes foot screening for people with type 2 diabetes will be provided by the primary care team (unless the patient has complicated diabetes in which case they will have routine screening in secondary care) with referral to podiatrists and secondary care guided by the care pathway (figure 1). In this way patients with low risk diabetic foot disease will not require foot screening by the podiatry services and will be treated in primary care, and patients with diabetes foot problems will be managed by community or hospital based podiatrists as part of a FPT / MDfT in one of the designated foot care centres. This Model of Care has been devised to allow a structured national programme to be put in place to reduce end-stage diabetic foot disease. It will be subject to ongoing review. 15

16 Revised MOC Draft 5_12.3.2018

2.5 Pathway for referral to the vascular service 2.5.1 Low risk foot If there are palpable pedal pulses on foot examination, referral for formal vascular assessment is not required. 2.5.2 Moderate risk foot Where a foot assessment identifies absent pedal pulses (or reduced ankle brachial pressure index) but no other abnormality, the patient should be referred to the FPT for assessment for protective orthosis / footwear, education and annual review. Where a patient is identified as having intermittent claudication and absent pulses, the following principles apply: The mainstay of treatment is risk factor modification (smoking cessation, antiplatelet therapy and statin therapy) (15). Supervised exercise has also been shown to be of benefit (16). Care is managed in primary care, by a specialised diabetes service or by referral to a vascular surgical service as agreed locally. Surgical treatment (including endovascular) is rarely indicated in the management of claudication without rest pain or tissue loss, particularly in those with diabetes. These referrals would normally be classified as routine by vascular surgery. 2.5.3 High risk foot Where there are absent foot pulses in a foot classified as at high risk the following principles apply: A vascular surgery opinion should be obtained either by direct referral or (preferably) through assessment in a multidisciplinary foot clinic which includes vascular surgery input (as locally agreed). Where there are symptoms of ischaemic rest pain in association with absent pulses, patients should be referred for urgent vascular opinion. Rest pain is pain in the foot (usually the forefoot) typically occurring at night and interfering with sleep. It is often relieved by hanging the foot out of the bed. Such referrals would be classified as urgent by vascular surgery. 2.5.4 Active foot ulceration Where there is ulceration, tissue loss and/or active sepsis in association with absent pedal pulses the following principles apply: Urgent assessment should be arranged in a local foot protection service, or the patient referred to the most appropriate A&E department for assessment. Early consultation with vascular surgery should be arranged as locally agreed, where there is evidence of ischaemia. Where there is evidence of necrosis, local spreading sepsis, or severe sepsis (with systemic signs), patients should be referred immediately for admission either via the local emergency department or the most appropriate A&E department within the hospital group as determined locally. Early consultation with vascular surgery should be arranged as locally agreed where there is evidence of ischaemia. 17

3.0 Care of the Low Risk Foot In this section: 3.1 Examination of the low risk foot 3.2 Management of the low risk foot A patient with a low risk foot has normal foot pulses, normal sensation, no significant foot deformity and no history of foot ulceration. 3.1 Examination of the Low Risk Foot 3.1.1 Foot surveillance: Uncomplicated Type 2 diabetes: Those at low risk should have their feet examined on an annual basis in general practice by an appropriately trained diabetic foot screener who is usually a practice nurse (level 1 foot surveillance). Ongoing foot inspections should be carried out in general practice as and when required and as part of routine care. The patient should also be advised to carry out regular foot inspections. Type 1 diabetes and complicated type 2 diabetes: Those at low risk should have their feet examined on an annual basis in secondary care by an appropriately trained member of the diabetes specialist team. The patient should also be advised to carry out regular foot inspections. 3.1.2 Screening: The standardised Diabetic Foot Screening Tool (appendix 1) should be used. Patients previously classified as low risk or patients with newly diagnosed diabetes mellitus should have the following foot examination performed: Inspection for structural foot deformity Skin and nail examination Vibration perception testing (128 Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament. Palpation of dorsalis pedis and posterial tibial foot pulses Presence or absence of intermittent claudication or rest pain Examination of footwear Findings of all assessments must be fully documented and recorded 18

3.2 Management of the Low Risk Foot There is no need for a patient with low risk feet to routinely see a podiatrist for diabetes foot care. If the risk category changes, referral to the FPT should be made using the appropriate referral form (appendix 2) and a completed Diabetic Foot Screening Tool (appendix 1) should accompany the referral. Foot care education should emphasise the importance of self-management and include education on: Nail care Skin care including emollient use Appropriate footwear Daily self-examination of the feet Preventative measures such as not walking in bare feet, checking footwear and hosiery before putting them on, not using hot water bottles, checking bath temperature, and avoidance of home remedies e.g. corn plasters. What to do and the appropriate person to contact if foot problems develop An information booklet on care of the low-risk foot should be provided to patients Insert link Annual foot screening as part of the patient s general diabetes care. Clinical Governance of patients classified as low risk rests with the patient s general practitioner. 19

4.0 Care of the Moderate Risk Foot In this section: 4.1 Examination of the moderate risk foot 4.2 Management of the moderate risk foot A patient at moderate risk of foot complications has: - Impaired sensation (a reduction in vibration sensation or 10g monofilament sensation), or - Impaired circulation (absent foot pulses in either or both feet), or - Deformity There must be no history of ulceration. 4.1 Examination of the moderate risk foot 4.1.1 Foot surveillance: Type 2 diabetes: An annual podiatry review should be performed by the community podiatrist Referral to the FPT should be made using the appropriate referral form (appendix 2) with a completed Diabetic Foot Screening Tool (appendix 1). Ongoing foot inspections should be carried out in general practice as and when required and as part of routine care. The patient should also be advised to carry out regular foot inspections. Type 1 diabetes: All patients with type 1 diabetes will receive foot screening in secondary care.. The patient should also be advised to carry out regular foot inspections. 4.1.2 Screening: Using the Diabetic Foot Screening Tool (appendix 1), patients previously classified as moderate risk should have the following foot examination: Inspection for structural foot deformity Skin and nail examination Examination of footwear Vibration perception testing (128 Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament Palpation of dorsalis pedis and posterior tibial foot pulses Presence or absence of intermittent claudication and rest pain A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial index and toe brachial pressure index calculation Findings of all assessments must be fully documented and recorded 20

4.2 Management of the moderate risk foot Patients at moderate risk should be reviewed annually by community podiatry or more frequently if required. If there is loss of vibration or 10g monofilament sensation the patient should be educated on how to protect their feet. Referral to a structured diabetes self-management education programme should be considered where appropriate. If there is intact sensation and absence of foot pulses in either or both feet, the patient may require further vascular assessment particularly if there are symptoms of vascular insufficiency. Advanced vascular testing in the clinical setting may also be indicated. See the pathway for referral to vascular services in section 2.5. If foot deformity interferes with the function of the foot, increases the risk of pressure related breakdown or the ability to obtain appropriate footwear, then the patient should be referred to podiatry / orthotist services for biomechanical assessment, advice and discussion of all treatment options including accommodative footwear and orthoses where required. Where this is indicated, the review should take place 6 weeks of referral. In some cases orthopaedic intervention may be required. Foot care education should emphasise the importance of self-management and include education on: Nail care Emollient use Footwear Daily self-examination of the feet Not walking in bare feet Checking footwear and hosiery before putting them on No hot water bottles Checking bath and shower temperature Avoidance of home remedies e.g. corn plasters What to do and the appropriate person to contact if foot problems develop An information booklet for care of the moderate-risk foot (Insert link) should given to the patient Clinical Governance: For patients attending GP or combined GP/ hospital care, clinical responsibility rests with the GP and podiatrist. For patients totally managed by the hospital clinics the clinical responsibility rests with the consultant (under the governance of the FPT or MDfT). 21

5.0 Care of the High Risk Foot In this section: 5.1 Examination of the high risk foot 5.2 Management of the high risk foot 5.3 Special considerations with the high risk foot A patient at high risk of foot complications has: - Impaired sensation together with impaired circulation or - Impaired sensation in combination with significant callus/deformity (based on clinical judgement) or - Impaired circulation in combination with significant callus/deformity (based on clinical judgement) or - Chronic kidney disease (stage 4 or 5) or - A previous history of ulceration, lower limb amputation or Charcot foot (i.e. a diabetic foot inremission). 5.1 Examination of the high risk foot 5.1.1 Foot surveillance: Refer those with a high risk foot to the FPT. Referrals should be made using the appropriate referral form (appendix 2) with a completed Diabetic Foot Screening Tool (appendix 1). Most patients with a high risk foot, should have 6-monthly review by a podiatrist in the FPT (level 3a foot surveillance) Those with a diabetic foot in-remission i.e. previous foot ulceration, amputation or Charcot foot, should have more frequent review (3-6 monthly) by the FPT (level 3b foot surveillance) Ongoing foot inspections should be carried out in general practice as and when required and as part of routine care The patient should also be advised to carry out regular foot inspections For those that attend the diabetes outpatient clinic, the specialist team will also perform routine screening 5.1.2 Screening: Patients classified as high risk should have the following foot examination: Skin and nail examination Inspection for structural foot deformity A comprehensive neurological assessment: Vibration perception testing (128 Hz tuning fork) and cutaneous pressure perception testing using the 10g monofilament Palpation of pedal pulses Presence or absence of intermittent claudication and rest pain A comprehensive vascular assessment where indicated, including Doppler waveform analysis, ankle brachial and toe brachial pressure index calculation 22

Examination of footwear Findings of all assessments must be fully documented and recorded. 5.2 Management of the high risk foot The podiatrist within the FPT at designated sites should review the high risk foot at least once every 6 months. The diabetes foot protection clinic should take place on a monthly basis at minimum, and should have input from a diabetes consultant, podiatrist and diabetes nurse with access where necessary from vascular and orthopaedic specialists, and orthotists. If ulceration is present then refer within 1 working day to the MDfT (in a model 3 or model 4 hospital) for review within 24 hours or the next working day. Review educational needs of the patient. Refer to a podiatrist / orthotist for footwear assessment and orthoses provision as required. Where this is indicated, the review and fitting should take place within a maximum of 6 weeks of referral. Refer to the vascular team where necessary. See the pathway for referral to vascular services in section 2.5. If necessary, refer to the orthopaedic team. The hospital podiatrist will work closely with the community podiatrist in the joint care of high risk foot patients. Foot care education should emphasise the importance of self-management and include education on: Nail care Skin and nail examination Emollient use Footwear Daily self-examination of the feet Not walking in bare feet Checking footwear and hosiery before putting them on No hot water bottles Checking bath and shower temperature Avoidance of home remedies e.g. corn plasters Avoidance of constrictive hosiery What to do and the appropriate person to contact if foot problems develop An information booklet for care of the high-risk foot should be given to the patient Clinical Governance: For patients attending GP or combined GP/ hospital care clinical responsibility rests with the GP and podiatrist. For patients totally managed by the hospital clinics the clinical responsibility rests with the consultant (under the governance of the foot protection team or multidisciplinary diabetes foot care service). 5.3 Special considerations with the high risk foot 5.3.1 The diabetic foot in remission Maintaining a state of remission in a high-risk diabetic foot is one of the most complex aspects related to the management of diabetic foot complications. In patients who have already had a diabetic foot ulcer, the risk of another developing in the next three years is 17% 60% (10). A 23

patient with a healed diabetic foot ulcer should therefore be considered in remission rather than cured. Secondary prevention of ulceration is backed by strong data (10). Research has consistently pointed to pressure relief strategies to reduce risk of re-ulceration in patients in diabetic foot remission. When an ulcer is approaching complete epithelialisation, foot orthoses and customised footwear should be ordered or availability ensured where appropriate. Where orthoses / customised footwear are indicated, the orthotist review should take place without delay, and be fitted within a maximum of 6 weeks of referral. The patient should be referred to a FPT for 3-6 monthly review (or more frequent as required). If there is concern, they should be seen within 1 week and reviewed more frequently. There should be clear locally-developed referral pathways between community podiatry, the FPT and the MDfT to support the management of this highrisk group. These patients should receive education on how to perform foot examinations, and should be encouraged to perform these regularly, as patient involvement is central to prevention. Patients should be reminded about who to contact if they develop any problems. Ongoing care of these patients is provided by the diabetes specialist team and/or the GP and practice nurse. 5.3.2 Preventative care for inpatients at risk of heel ulceration Diabetes is a major risk factor for heel pressure ulcers. Heel ulceration is reported to be the second most common type of pressure ulcer during a hospital stay and is particularly serious in people with diabetes as it is associated with amputation (11) (17), Risk factors for developing heel pressure ulcers include peripheral arterial disease, diabetic neuropathy, limb immobility and dementia. For this reason, early foot screening and continued monitoring is very important. The following points should be considered: Hospital staff should be familiar with the diabetic foot Check, Protect and Refer protocol, known as CPR for Feet (insert link). CPR for Feet aims to ensure that at-risk patients do not develop an avoidable foot ulcer during their stay in hospital. CPR for Feet also aims to ensure that those who are admitted to hospital with a current foot ulcer or tissue necrosis are referred appropriately. Staff education programmes on pressure ulcers should highlight the particular risk of those with diabetes and raise awareness of CPR for Feet. Every patient with a diagnosis of diabetes in any healthcare setting should be assessed regarding the risk of pressure ulceration. The simple Ipswich Touch Test (insert link) (also known as the Touch the Toe Test) is an acceptable test to screen for sensory impairment in inpatients, where sensory screening equipment might not be readily available to ward staff (18). Those at risk should have their feet protected with an appropriate pressure relieving device. Ward staff should be educated about the importance of ensuring that those with diabetes who are admitted to hospital with a foot ulcer or foot infection are referred appropriately to the MDfT. 24

Any Stage 3 or 4 pressure ulcer acquired after admission to a health and social care residential facility must be reported, as it is deemed by the HSE to be a Serious Reportable Event (See section 7.1) 5.3.3 Diabetic foot care in people with renal disease End stage renal failure (ESRF) and chronic kidney disease (CKD) stages 4 5 (egfr < 29 ml/min/1.73 m2) are independent risk factors for diabetic foot disease, with associated neuropathy, peripheral arterial disease and delayed wound healing. Dialysis is independently associated with a >4-fold risk of foot ulceration (12). Neuropathy greatly increases the risk of pressure related ulcers, particularly on the heels of recumbent patients. Strategies to prevent ulceration in this group include: All patients with diabetes on dialysis should be considered high risk and should have at least 6-monthly review by the FPT (or more frequent as required). All patients with diabetes on dialysis should have their feet inspected at least weekly by competent staff on the dialysis unit. The heels and bony prominences of all patients with diabetes on haemodialysis should be protected with a suitable pressure relieving device during haemodialysis. If the patient has an ulcer or there is any other concern the patient should be referred to the MDfT within one working day. If the patient is on home dialysis it is the responsibility of the clinician in charge of their care (nephrologist or diabetes consultant) to ensure that the patient has a 6- monthly foot review by the FPT. Charcot Foot is also associated with renal disease. Any patient presenting with a hot swollen foot should be referred to the MDfT within 24 hours for review within a further 24 hours or the next working day. As outlined later in section 6.3, the recommended treatment of an acute Charcot foot is offloading in a non-removable cast or walker. However, patients on renal replacement therapy may tolerate this poorly due to changing peripheral oedema. Other methods of offloading (for example removable cast and wheelchair use) may be required. 25

6.0 Care of Patients with Active Foot Disease In this section: 6.1 Care pathway for active foot disease 6.2 Diabetic foot ulceration 6.3 Charcot foot 6.4 Diabetic foot infection 6.5 Critical limb ischaemia A patient with active foot disease has: An active foot ulcer (defined as a full thickness skin break) or Suspicion of an acute Charcot foot (or an unexplained hot, red, swollen foot with or without pain) or Spreading infection or Critical limb ischaemia 6.1 Care pathway for active foot disease The care pathway for people with active foot disease, which is outlined in detail later in this section, is summarised in figure 2. 6.1.1 Foot surveillance Those with active foot disease are managed by the multidisciplinary diabetes foot team and require level 4 foot surveillance: Refer within 24 hours for MDfT review within a further 24 hours or the next working day Very frequent review by the MDfT (weekly or as required) Ongoing care by the diabetes specialist team Ongoing care in general practice Ongoing self-care If concern, the MDfT should see the patient urgently (within 24 hours) 6.1.2 Referral to the multidisciplinary diabetes foot team (MDfT) Urgent Referral to the MDfT All patients with a diabetic foot ulcer or active Charcot foot should be referred to the diabetes foot clinic urgently and patients should be seen within 24 hours or on the next 26

working day by the multidisciplinary diabetes foot care service, and involve the appropriate specialties. The appropriate (locally approved) diabetic foot ulcer assessment and referral form should be used. Immediate referral to the MDfT If a patient has a limb-threatening or life-threatening diabetic foot problem, refer them immediately to A&E and inform the MDfT so they can be assessed and an individualised treatment plan put in place. Examples of limb-threatening and life-threatening diabetic foot problems include the following: Ulceration with fever or any signs of sepsis Ulceration with limb ischaemia Clinical concern that there is a deep-seated soft tissue or bone infection (with or without ulceration). Tissue necrosis / gangrene (with or without ulceration). For all other active diabetic foot problems, refer the person within 1 working day to the MDfT for clinical review within one further working day. Admission to hospital of a person with a diabetic foot problem Within 24 hours of a patient with a diabetic foot problem being admitted to hospital, or the detection of diabetic foot problems (if the patient is already in hospital), they should be referred to the MDfT for review within a further 24 hours, or one working day Each hospital should have a care pathway for people with diabetic foot problems who need inpatient care. 6.1.3 Clinical governance active foot disease The clinical governance for managing outpatients with active foot disease is with the consultant leading the MDfT i.e. the local diabetes consultant and the examiners will be members of the hospital diabetes MDfT. If the patient is admitted to hospital, the named consultant under whose care they were admitted, should remain accountable for the care of the patient. If the responsibility of care is transferred to the MDfT, then the responsibility of care is with the consultant diabetes consultant in the MDfT. 27

28 Revised MOC Draft 5_12.3.2018