Major amputation incidence is justifiably a key performance indicator for foot services because of its widely-reported impact on quality and length of life (Jupiter et al, 2016). Timely access to care has been identified as a major factor in improving healing rates and reducing amputation risk (National Institute for Health and Care Excellence [NICE], 2004, 2012, 2017; Jeffcoate et al, 2014). Diabetes UK has been promoting the benefits of robust diabetic foot services for more than a decade, but there are still widespread gaps in service provision and inequalities between providers.
Cardiovascular disease, stroke and cancer services are subject to audit, peer review, national data reporting and annual performance review. As a result services and outcomes have improved (Birkhead et al, 2004; Royal College of Physicians, 2006; Williams and Drinkwater, 2009). Diabetic foot disease has only recently been subjected to this level of scrutiny, despite being characterised by: a preventable precursor stage; manageable early risk factors (Jeffcoate and Young, 2016; Paisey et al, 2016, 2018); the potential to avoid initial significant tissue loss (Paisey et al, 2019); and possible avoidance of end-stage critical limb damage that requires urgent intervention (British Orthopaedic Association et al, 2016). The fact that diabetic foot disease problems cost 1% of the NHS budget per annum and improving care reduces this burden (Kerr et al, 2019; Paisey et al, 2019) should act as a stimulus for care providers to prioritise the issue. However, the prevention and prompt treatment of diabetic foot ulcers (DFUs) remains challenging because of the multifactorial nature of the problem and the demands of sustained, integrated care. The key performance indicator for the success of a diabetic foot service is the incidence of major amputation; rates above the NHS England national average highlight potential failures in overall service provision (Holman et al, 2012). This, however, does not identify specific gaps in services.
Diabetic foot care peer review
NHS England South West (SW) sought to investigate the variable but mostly high major diabetes-related amputation rates in the SW region using peer review. The process identified wide variation in the timely provision of care, including patient education, quality of general practice annual reviews, access to community podiatry and multidisciplinary foot protection services (Paisey et al, 2018). Less obvious but equally important barriers to good care include a lack of robust administrative support and clarity and accessibility of diabetic foot pathways.
Over 100 patients living with DFU were interviewed (four in each provider centre) to evaluate barriers to prompt assessment and treatment. Each provider centre was visited by a team made up of a lead podiatrist, vascular surgeon, diabetologist and orthopaedic surgeon, none of whom worked in the location reviewed. Visits were completed within 1 working day.
In every review, the team sought to engage community and hospital service providers, clinical commissioning group (CCG) leads, GP leads, providers and local hospital trust board representatives. Notably, in contrast to stroke, cancer and cardiovascular services, diabetic foot care was poorly understood and inadequately represented at CCG and hospital board level. Lack of representation at executive level may partly result from the complex nature of the disease and the absolute requirement for multidisciplinary care and cross-pathway provision, including general practice and community services. The standards of care found to be linked with satisfactory diabetic foot care from the peer reviews are given in Table 1.
Public Health England (PHE)’s diabetes complications reports that include amputation rates do not separate different providers within a CCG. The authors sought to shed more light on the details of care provision in each provider within the CCGs with some success, as their amputation rates and challenges varied widely.
The PHE statistics also rely on 3-year outcomes to enhance reliability of findings. The authors have reported 1-year changes where significant improvements to service have occurred to assess effects quickly to make sure that the changes have started to help. The mechanism for obtaining these statistics is that the CCG data analysts can interpret Secondary Uses Service data to separate provider areas in the CCG and generate 1-year statistics.
Where providers were able to implement the 10 key services, there was a direct correlation with a reduction in amputation rates, see Table 2 and Figure 1. Notable changes included:
- Improved uptake of diabetic foot screening
- Foot Risk Awareness and Management Education (FRAME) tool use (NHS Scotland et al, 2017) in GP practices to improve standards of diabetic foot checks
- Development of streamlined referral pathways
- Link podiatrists working closely with groups of general practices
- Appointment of inpatient podiatrists
- Job planning and audit of multidisciplinary diabetic foot teams (MDFTs)
- Establishment of virtual MDFTs for rural areas
- Prospective root cause analysis (RCA) of major amputations
- Use of digital technology to document accurate vascular assessment, including toe pressures
- Identification of inpatients with diabetes and recording of their foot status
- Sharing records and ulcer photographs.
Amputation root cause analysis
The causative factors that led to both major and minor amputations were notable in services where RCAs were routinely undertaken. The hospital- and podiatry-based investigation of factors leading to amputation in over 30 cases in one CCG led to a misleading conclusion. There was an assumption that inadequate annual review and failure of prompt referral to podiatry could be blamed for half of the amputations. A full pathway and system approach, as developed in the Diabetes UK RCA guide (Diabetes UK, 2016), led to a much better understanding of the situation. Thorough review of general practice records demonstrated just how hard most practices had endeavoured to engage with their patients and how they had followed existing referral pathways. Pathways that delay timely referral because of restrictions on patient self-referral continue to be a problem. Untrained staff are expected to triage foot ulcer referrals in many areas, especially where there is a single point of referral for all allied healthcare professional services.
Identifying inequalities and gaps in provision and reconfiguring services
Large CCGs covering several hospitals can provide greater flexibility in commissioning; however, audit of diabetic foot services must be refined to explore any differences in outcomes within CCG maps (Figure 2 and Figure 3). This is particularly important in order to share good practice. It must be recognised that different provider areas within large CCGs (or sustainability and transformation partnerships) may need to provide services configured according to population and geographical characteristics within the CCG.
A strong community podiatry team, rotation into the MDFT and daily hospital ulcer clinics in addition to the MDFT itself are the foundation of excellence in treatment of diabetic foot disease. Inpatient podiatry provision is also essential. In one area, the development of a virtual MDFT linked with community podiatrists has more than halved the major and minor amputation rates in the 2 years since its inception (White et al, 2019). The process relies on ulcer photographs attached to emailed referral forms. Over half of patients referred can be treated without seeing the MDFT face-to-face. The shortage of podiatrists since the withdrawal of training bursaries is a serious concern. Apprenticeship training schemes for allied healthcare professionals may be of future benefit.
Poor outcomes for aneurysm surgery in the UK necessitated a reorganisation of vascular services in England. A hub-and-spoke (arterial and non-arterial centre) model was proposed and a gradual transformation of service delivery commenced in 2012 as part of specialist commissioning. One consequence of the centralisation of major vascular interventions to a regional arterial centre was the inevitable reduction in vascular surgical presence in the MDFT and reduction of vascular inpatient beds in the non-arterial centres. This has the potential to delay diagnosis and treatment in spoke hospitals and increase pressure for DFU investigations and treatment in hubs. Data have shown that in three areas the move to an arterial hub-and-spoke model has been associated with increased diabetes-related amputations (Public Health England, 2019). A possible mitigating factor may be the continued clinical preference for endovascular intervention in persons with DFUs complicated by peripheral vascular disease. Angioplasty can often still be undertaken in non-arterial centres if vascular service review is available when required. Combining this with orthopaedic intervention for non-ischaemic diabetic foot problems in the non-arterial centre would seem a logical way forward.
Peer reviews of diabetic foot services throughout the SW and Wessex regions have highlighted an inequality in orthopaedic expertise in the MDFT. Orthopaedic availability ranges from no foot and ankle surgeon along with limited access to plaster of Paris casting, to MDFT leadership by podiatric surgeons with dedicated operating theatre sessions. In some centres, enthusiastic orthopaedic surgeons offer a prompt and innovative intervention for recurrent ulceration and osteomyelitis.
The majority of secondary care orthotics services for all conditions are commissioned piecemeal from independent providers. This commissioning may exclude any link with the MDFT. Delays in the provision of bespoke footwear or devices ranged from weeks to 6 months. With adequate space and the presence of an orthotist in the MDFT, biomechanics can be fully investigated and the findings brought to bear on choice of orthosis. Counselling is a crucial part of this service, to avoid the futility of an expensive shoe being disposed of unworn by patients, and needs to be integrated in this service.
There are many vacancies in the endocrinology and diabetes workforce and few diabetologists are keen to take the lead in a MDFT. The average HbA1c in DFU patients is 70–80 mmol/mol (8.6–9.5%) or higher (Paisey et al, 2016), contributing to the development of ulceration, impaired healing and predicated future complications of diabetes. It may be that in future an experienced diabetes specialist nurse could provide some diabetes care in the MDFT, in particular, engaging with the patient to improve glycaemic control. Where diabetes specialist nurses are prescribers, they will be able to offer appropriate therapeutic interventions. The availability of a diabetologists to consult to the MDFT is highly desirable.
Acute services (hot red foot)
Just as integrated diabetes foot care is underrepresented at CCG and trust board level, the acute diabetic foot patient is often neglected at presentation to acute services. Failure of thorough examination and basic investigations can result in many hours or days of delay before intensive therapy is begun. Good medical, nursing and podiatry practice should ensure prompt treatment and referral.
Within 1 hour of arrival to hospital
Both feet must be off-loaded immediately on arrival, including the removal of all footwear and dressings, with a bed cradle and relief of heel pressure implemented. Full blood count, renal function, blood glucose and C-reactive protein tests should be performed. The results should be reported within 1 hour for critical patients. Possible ischaemia should be assessed and the presence of infection determined. If patients present in shock, practitioners should follow the national guidelines for the management of septicaemia.
Within 4 hours of arrival to hospital
Glycaemic control should be managed according to capillary blood glucose monitoring within 4 hours. Where infection is diagnosed, intravenous antibiotics need to be commenced within 4 hours of arrival in hospital. Unless contraindicated, prophylactic subcutaneous heparin should be administered within this period.
National initiatives to be considered
Quality and Outcomes Framework
The new Quality and Outcomes Framework guidelines recognise the need to modify insulin and oral hypoglycaemic agents according to frailty and the consequent risk of serious hypoglycaemia (NHS Digital, 2018). This can be of particular importance for patients treated by the MDFT, as insulin resistance may decline sharply following successful treatment of osteomyelitis or the amputation of ischaemic toes. Good glycaemic control (<58 mmol/mol; <7.5%) achieved by therapies with a low risk of hypoglycaemia benefits wellbeing and reduces the risk of long-term complications; however, less tight control (70–75 mmol/mol; 8.6–9.0%) is safer for frail patients on insulin with limited life expectancy, unless the risk of hypoglycaemia can be minimised.
An important corollary of this concerns Quality and Outcomes Framework exemption from practice annual review. Whatever the reason for non-attendance, the outcomes are poor for patients with diabetes (Kontopantelis et al, 2016). Older, multimorbid and more deprived patients are more likely to be exempted from the scheme. More research is needed to confirm the clinical impression that these groups are at proportionately greater risk of DFU.
National Diabetic Foot Audit (NDFA)
NDFA data show that timely referral to diabetic foot services on first presentation of a DFU and timely access to associated services is linked to improved healing times, as measured by ulcer-free survival at 12 weeks (NHS Digital, 2019). There is a strong case for mandatory participation in the NDFA for all community and secondary care diabetic foot care providers.
Prevention and service planning are key
Tertiary prevention of diabetes encompasses damage limitation and rehabilitation once a DFU has developed. There are multiple factors in the progression from a vulnerable foot to the development of DFU and amputation. Effective team working across disciplines is crucial to the provision of effective diabetic foot care. There is real hope that — with inclusive multidisciplinary working, RCA and NDFA — DFUs can be prevented and, where they occur, treated with alacrity to avoid amputation. This will require cogent commissioning, responsive, locally-sensitive provision of care and adequate funding from CCGs. Rigorous assessment of commissioned services is of the essence. Future-proofing services with appropriate skill mixing, capacity and succession planning are all essential.
In the 5 years since the SW peer reviews were completed there have been excellent examples of successful incorporation of digital technology to support better access to care. Governance and leadership by lead vascular surgeons, diabetologists, podiatrists and general practice staff is necessary. These practitioners, orthotists and orthopaedic surgeons are essential members of the MDFT.