Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr David Russell
-
davidrussell1@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - DOMINO-DFU: A study looking at optimising diagnosis of bone infection in people with a diabetic foot ulcer
Back

DOMINO-DFU: A study looking at optimising diagnosis of bone infection in people with a diabetic foot ulcer

Recruiting

Open to: All Genders

Age: Adult

London Birmingham Leeds

Medical Conditions

Osteomyelitis in diabetes with foot ulcer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Diabetes affects 4.5 million adults in the UK, a quarter of whom will develop a diabetic foot ulcer (foot wound; DFU). One in five people with a DFU will develop ‘high-risk characteristics’ of infection in the bone underlying the wound (osteomyelitis; DFO). The treatment for this is usually 6 weeks of antibiotics, but in some it needs an operation to remove the infected bone, often with a toe or foot amputation. There is no “gold-standard” diagnostic test and current diagnostic strategies may over-diagnose DFO in up to one-third of people, meaning an unnecessary prolonged course of antibiotics.
This study aims to answer three questions to improve the diagnosis of DFO:
1. What is the current clinical standard for diagnosis of DFO?
2. Which of the two bone sampling methods gives the best results for the diagnosis of DFO?
3. Can we better diagnose DFO using a combination of wound appearance, blood tests and X-ray?

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Aug 2021 31 Aug 2025

Patients who agree to be part of the full cohort will have information collected from their medical notes.
Patients who develop high-risk characteristics of osteomyelitis will have additional information collected from their medical notes, and be asked whether they would like to complete questionnaires (this is optional).
In the future (pending approval) we will ask patients who develop high-risk characteristics of osteomyelitis to have 2 bone samples taken when they are identified as having high-risk characteristics.


All patients with a new DFU attending multidisciplinary (MDT) diabetic foot ulcer service clinics can take part in the full cohort.
Patients who develop high-risk characteristics of osteomyelitis may also take part in a high-risk cohort.

You can take part if:



You may not be able to take part if:


No exclusion criteria for full clinical cohort or phase 1 and 3 high-risk cohorts (as advised by PPI members).

High-risk phase 2 diagnostic concordance study cohort:1. Unable to undergo both ‘through-the-ulcer’ and ‘remote’ bone biopsies2. Would not be ethically appropriate to approach the patient e.g. on end of life care


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St George’s Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Sandwell and West Birmingham Hospitals NHS Trust
    City Hospital Dudley Road
    Birmingham
    B18 7QH
  • Leeds General Infirmary
    The Leeds Teaching Hospitals NHS Trust Great George Street
    Leeds
    LS1 3EX

There are no direct benefits of taking part in the study, participation will help to improve the diagnosis of osteomyelitis in the future.
Patients will be asked to give up some of their time to take part.
In the future (pending approval), patients who have bone samples taken may experience some discomfort or bleeding when the samples are taken.

Mr David Russell
-
davidrussell1@nhs.net



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leeds and funded by NIHR Academy; Grant Codes: NIHR300633.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN93847463

Or CPMS 49009

Last updated 12 February 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top