Evidence
Alert

People with diabetes with a low risk of developing foot ulcers can be screened less often, study suggests

People with diabetes are at increased risk of developing foot ulcers. Current NICE guidance recommends that they have their feet screened annually to identify those most at risk.  But a new study suggests that annual foot checks could be scaled back. It found that people at low risk of developing ulcers do not need annual reviews.

Just one in twenty (5%) of people at low risk progressed to medium risk after two years, the research found. And just one in 250 developed ulcers in that time. After a further six years, the majority of these patients (90%) were still classed as low risk.

The results suggests that, for those identified as low risk, screening every two years may be acceptable. Less frequent screening would limit the number of face-to-face contacts required of the patient. It would also save on NHS resources which could be redirected to other aspects of preventative diabetes foot management.

What’s the issue?

Up to one in three people with diabetes develop ulcers on their feet (estimates range from 15-34%). Half of those with ulcers develop infections and severe complications that may result in amputation.

Current NICE guidelines state that people with diabetes should have their feet examined annually for risk of developing a foot ulcer. For those judged to be at high risk, screening can be as frequent as once a week.

There is little clinical evidence to determine how often people at low risk of ulcers should have their feet checked. It’s possible they could be shifted to screening every two years, to free up scarce NHS resources. Before this study, there was no clear evidence on the likely effects of such a change – and whether it would leave some people more likely to develop potentially damaging ulcers.

What’s new?

The study analysed data on 10 421 people diagnosed with diabetes who had their first visit to screening clinics in Fife, Scotland between 2009 and 2017. The team identified each person’s risk of foot ulceration according to standard risk factors of insensitivity, previous ulcers, and whether pulses in the foot could be felt. They looked at the change over time – from low to moderate risk. They cross-referenced this information with data on ulceration, amputation and death.

The results showed:

  • People with diabetes changed from low to moderate risk slowly
  • One in twenty (5.1%) low-risk patients became moderate-risk after two years
  • Around one in ten changed from low to moderate risk after five years (9.9%) and eight years (11.3%)
  • Most changes in risk status (94%) were down to nerve damage in the feet (peripheral neuropathy)
  • One in 250 (0.4%) in the low-risk group developed ulcers after two-years; one in a thousand (0.1%) had an amputation.

These findings are reassuring for people with diabetes at low risk of developing ulcers.

Why is this important?

Current NICE guidelines recommend that people with diabetes have a foot examination every year. For those judged to be at moderate or high risk, monitoring is escalated to 6 monthly intervals and then up to a maximum frequency of once per week.

Annual screening for people at low risk requires considerable NHS resource, at the expense of other preventative strategies or treatments. There is no clear evidence to support this recommendation; the optimal frequency of screening is unknown.

This uncertainty - and the need to manage scarce resources - has prompted a debate in Scotland about whether people with diabetes who have a low risk of foot ulcers could be screened less often, perhaps once every two years. These findings suggest that such a change would not cause clinical problems for the overwhelming majority of people. The results have been passed on to the Scottish government.

What’s next?

The Diabetes Managed Clinical Network (Diabetes MCN) in NHS Fife will discuss the findings as part of a proposal to deliver foot screening for people with diabetes with a low risk of foot ulcers every two years.

Researchers are also raising awareness of their findings among policy-makers and clinicians, including attendees at national diabetic foot conferences, College of Podiatry members, national and international clinical guideline developers.

Further research is needed to better understand who attends foot screening and the nature of advice, preventative care or treatment they receive. It is also needed to assess whether clinics, including those beyond the study area, are providing uniform care.

You may be interested to read

The full study: Heggie R, and others. Complication rate among people with diabetes at low risk of foot ulceration in Fife, UK: an analysis of routinely collected data. Diabetic Medicine. 2020;37:2116-2123

The full NIHR Journals Library report, detailing this, and related, research:  Crawford F, and others. Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model. NIHR Health Technology Assessment. 2020;24:1-232

Previous work by the same group on foot ulcer risk assessments: Crawford F, and others. A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS). Health Technol Assess. 2015;19:1-210

Current NICE guidelines on foot screening frequency: Diabetic foot problems: prevention and management [NG19] (2019)

Funding

The study was funded by the NIHR Health Technology Assessment programme.

Commentaries

Study author

The proportion of people with diabetes who changed risk status, developed ulcers and required amputation was less than we expected. We believe that this is the result of the high proportion of low-risk people within this cohort. The rate of change from one risk state to another has never been clearly demonstrated before. This new knowledge generates new research questions: who changes risk score, why they change and when they change.

Our work is particularly relevant to clinicians and clinical guidelines developers, such as NICE and the Scottish Intercollegiate Guideline Network (SIGN). But members of the public who have diabetes may also find these results interesting.

Robert Heggie, Health Economist, University of Glasgow

Diabetes UK

The results of this research study are encouraging, but we would need assurances before we could support a policy change in frequency of foot checks across the UK for people with diabetes. The quality of foot checks can vary from area to area. The quality of the checks and the consistency of the assessment of foot risk would need to be assured before we could confidently support a wholesale move to a lower frequency of checks.

Any change for an individual in the frequency of their foot checks should be made on a case by case basis taking a person-centred approach. Any change in policy should be constantly monitored and reviewed. Foot ulcers and amputation are not only devastating for people with diabetes but very costly to the NHS. It would be important to ensure that any savings from a change in frequency of foot checks were retained within diabetes footcare to ensure continued improvements for people with diabetes and a reduction in amputation rates.

Nikki Joule, Policy Manager, Diabetes UK

Consultant diabetologist

The paper could have great impact in reducing frequency of foot screening in people with low-risk feet, which is a relatively time consuming and thus expensive procedure. It could also reduce anxiety amongst people with diabetes in this low-risk category about their risk of limb loss.

GPs are remunerated through a scheme that aims to reward good practice and currently includes an annual foot assessment for people with diabetes. National policy would have to be changed in order for them to feel comfortable about NOT checking feet annually. There would need to be reassurance about the competency of those performing the screening as currently there is no nationally approved training or competency assessment for foot screening. This contrasts with eye screening, in which a certain proportion of screens are rechecked.

The frequency of eye screening is also being discussed. It would help to tie these two screening procedures together in one policy change if they are to be implemented.

Fran Game, Director of Research and Development, University Hospitals of Derby and Burton NHS Foundation Trust

Conflicts of Interest

None declared.