Evaluation of foot screening in primary care in people with diabetes in England

Study type
Date of Approval
Study reference ID
Lay Summary

Diabetes, a disease characterised by high blood sugars, is common affecting 1 in 10 of people in the UK. It can cause major circulatory and nerve damage, predisposing to tissue damage of the feet that may lead to leg amputation. General Practitioners have been encouraged to detect the early signs of foot disease through their NHS contract in 2004. Specialist treatment could then be offered to reduce the chances of amputation. However, we do not know whether this programme to find the early signs of foot disease has been effective in lowering the numbers of amputations.

Our study will evaluate screening for foot disease in primary care. It will investigate whether:
i. number of amputations in patients with diabetes have decreased since the introduction of screening in 2004
ii. primary care screening examinations effectively pick out patients at high risk of amputation
iii. screening can be improved by a computer model to predict amputation risk
iv. patients with diabetes receive screening fairly, irrespective of age, gender or social position

Design and methods:
The study will use a large, anonymised database of general practice records called Clinical Practice Research Datalink, which is linked to hospital data, to answer these questions. The analysis will provide important information on whether current care for patients with diabetes in England is effective in preventing amputations and whether screening could be improved using a computer model to assess individual risk.

Technical Summary

Diabetes mellitus affects 4.9 million individuals in the United Kingdom. Approximately 25% of patients with diabetes develop foot ulceration during their life and 80% of amputations are preceded by a foot ulcer. Since 2004, General Practitioners in England have been encouraged to perform annual foot screening for patients with diabetes. It remains unclear whether the introduction of screening has affected patient outcomes.

The aims are to investigate:
1. The effectiveness of screening for the early signs of foot disease in diabetes in primary care
2. The predictive performance of the screening tests
3. The equity of uptake to identify opportunities for optimising care

Aim 1 will be addressed using controlled interrupted timeseries to examine amputation rates in populations with and without diabetes and the effect of the introduction of primary care incentives in 2004 on these trends. A sensitivity analysis will be performed for 2004-2010 and 2011-2019 periods to reflect the modification of the screening criteria.

Aim 2 will be achieved using a retrospective cohort design with the outcome of screening tests among people with diabetes as the main exposure and amputation as the main outcome.

Aim 3 will be addressed using a repeat cross-sectional design to examine the relationship between uptake of screening and demographic and clinical characteristics. A multidisciplinary panel meeting composed of patients and relevant stakeholders will be held to discuss current issues with foot screening and formulate recommendations for future improvements.

Impact and dissemination:
The results of the study will be presented at the national and international vascular and diabetes meetings and published in leading peer-review journals by the end of 2027. The findings will provide good quality evidence to either support ongoing foot screening in the community or encourage development of alternative interventions to improve outcomes in patients with diabetic foot disease.

Health Outcomes to be Measured

Major lower limb amputation (composite of below the knee, above the knee, through knee and hindquarter amputations); admission to hospital for foot related problems, length of hospital stay, foot ulceration, death; revascularisation procedure (any of extra-anatomical bypass, iliac bypass, iliac angioplasty, femoro-proximal bypass, femoro-distal bypass, femoral angioplasty, unspecified lower limb angioplasty


Robert Hinchliffe - Chief Investigator - University of Bristol
Robert Hinchliffe - Corresponding Applicant - University of Bristol
Aleksandra Staniszewska - Collaborator - University of Bristol
Frank de Vocht - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of Bristol


HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;CPRD Aurum Ethnicity Record