Diabetic Foot Ulcers - latest research

Diabetic Foot Ulcers - latest research

Descriptions of 3 Diabetic Foot Ulcer (DFU) research studies and update for lay groups

These descriptions of research into treatment of Diabetic Foot Ulcers are examples of research being carried out currently.  These three studies are examples of research which does not involve giving any new, experimental drugs and don’t involve any new procedures which are not already carried out in NHS hospitals.

  For various partly-historical reasons, different hospitals use different treatment methods. The aim of these research studies is to find out which are the most effective methods.

  Although these particular research studies are based in Leeds, they also cover other sites, including our own Sheffield hospitals, and the Chief Investigator for the first (MIDFUT study) is Sheffield's Professor Simon Heller.


MIDFUT (Multiple Interventions for Diabetic Foot Ulcer Treatment Trial)

(NIHR funded)

Looking at the effectiveness of additional wound treatments or dressings for diabetic foot ulcers which are not healing. Patients are randomised to receive ‘usual care’ (gold standard multi-disciplinary team assessment and management) or the addition of a once only treatment. Patients are followed up for 1 year during their usual clinic appointments.

The study started recruiting in 2017. 122 patients had been recruited from centres across the UK prior to trial closure due to COVID. The option to reopen was given in August 2020, so far 4 sites have re-opened, and patients are being recruited. The study is aiming to recruit 459 patients by 2023.

If you would like to know more about this study please contact midfut@leeds.ac.uk

CODIFI-2 COomparison of tissue sampling with swab sampling methods In DIabetic Foot Infections

(NIHR funded)

The CODFI-2 study is looking at which is the best way of taking and testing samples to confirm infections in diabetic ulcers & use of antibiotics to treat these infections. Patients attending clinic with a suspected infection in their foot ulcer are invited to join the study. A wound swab or small sample from the ulcer is collected once at this visit and information collected about which antibiotics they are given. Patients are followed-up for up to 2 years, mainly through routine clinic visits or from their routine medical records.

The study was opened to recruitment in 2019. There are 19 centres recruiting patients throughout the UK with a further 11 centres getting ready to join the study. The study has continued to recruit patients throughout the COVID pandemic and recruitment is expected to continue until October 2022.

If you would like to know more about this study please contact ctru-codifi2@leeds.ac.uk


DOMINO-DFU Diagnosis of OsteoMyelitis:INvestigation Optimisation in Diabetic Foot Ulcers

This study is looking at the best way to diagnose osteomyelitis (bone infection) in diabetic ulcers and will be recruiting patients in 3 phases over three years starting in Spring 2021. We are looking to recruit all patients attending diabetic foot clinics with ulcers in 3-4 recruiting centres, with minimal data collection over one year for most people. For those people who develop high-risk features suggestive of bone infection (e.g. bone at the base of the wound) we will be asking for some more detailed follow-up from medical records and at usual clinic appointments, and offering the option of completing some additional questionnaires. For these high-risk people in phase 2 of the study we will also be asking to take an extra bone sample. We expect recruitment to continue until late 2024.

If you would like to know more about this study please contact domino-dfu@leeds.ac.uk 


Dr Elizabeth McGinnis, Honorary Clinical Associate Professor, Clinical Trials Research Unit, University of Leeds,