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What is a diabetic foot ulcer?

Diabetic foot ulcers are wounds on the feet that occur in people with diabetes, mainly due to nerve damage causing areas of high pressure when walking.

What is osteomyelitis?

Most wounds have bacteria on their surface, and if there are enough bacteria this can cause infection. This is why it is important to keep wounds clean and dry. Areas of high pressure usually occur over a bony prominence, and if a wound in one of these areas is deep, then the bone at the bottom of the wound can also become infected, a condition called osteomyelitis.

What is the purpose of this study?

We are looking to;

  • Recruit everyone with a new diabetic foot ulcer so we can see how common bone infection is amongst people with a diabetic foot ulcer
  • Try and improve the diagnosis of bone infection in people with diabetic foot ulcers who develop high-risk clinical features

There is no standard way to diagnose a bone infection, and at the moment doctors and podiatrists use different ways to decide on the diagnosis. There are risks associated with missing the diagnosis, and studies suggest that it may therefore be over-diagnosed leading to unnecessary prolonged antibiotic courses in some people.

For those with high-risk clinical features for bone infection, i.e. those appearances of the wound which may make your treating clinician consider a diagnosis of bone infection, we are looking to get additional information over 3 phases of the study:

  1. How are clinicians currently making the diagnosis and what are the outcomes (recruiting for 6 months)?
  2. Can we take a sample of bone in a different way to improve the diagnosis with fewer tests making an incorrect diagnosis (either wrongly making, or wrongly ruling out the diagnosis – recruiting for 18 months)?
  3. Can we produce a set of diagnostic criteria using the clinical features and the tests recommended in guidelines (blood tests, X-rays and bone sample) that improves diagnosis and clinical outcomes for patients (18 months recruitment)?

We hope that the results of the study will help change future guidelines and improve care and outcomes of patients with diabetic foot ulcers.

DOMINO-DFU patient information sheet

Please select the version which was used when you joined the study.

If you’re not sure which one you need, please contact the trial team at DOMINO-Patients@leeds.ac.uk

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