DOMINO-DFU

• Research type

  Research Study

• Full title

  Diagnosis of OsteoMyelitis: INvestigation Optimisation in Diabetic Foot Ulcers

• IRAS ID

  288653

• Contact name

  David Russell

• Contact email

  davidrussell1@nhs.net

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  4 years, 4 months, 26 days

• Research summary

  Diabetes affects 4.5million 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 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 unnecessary prolonged course of antibiotics.
  This study aims to answer 3 questions to improve the diagnosis of DFO:
  • What is the current clinical standard for diagnosis of DFO?
  • Which of 2 bone sampling methods gives the best results for diagnosis of DFO?
  • Can we better diagnose DFO using a combination of wound appearance, blood tests and X-ray?

  We will recruit all consenting patients with a new DFU attending specialist clinics in 3 hospitals over 3½ years. For most patients (~4550) information will be collected from clinical notes. This will identify the risk of developing DFO in low-risk patients. A proportion of patients will have wounds with high-risk features for DFO. In these patients we will obtain extra information in 3 phases:
  • Phase 1 (225 patients, 6 months): Information on: whether clinicians have diagnosed DFO, and if so, how; antibiotic usage; was treatment successful? In assenting high-risk patients in all phases, questionnaires on quality of life and healthcare resource use.
  • Phase 2 (192 patients, 18 months): After additional consent, both through-the-wound and remote bone samples will be taken. This will determine the “guideline-standard” technique.
  • Phase 3 (450 patients, 18 months): Patients will have “guideline-standard” bone sample technique, blood tests and X-rays. A diagnostic guide will be developed based on this information.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/PR/0407

• Date of REC Opinion

  16 Jul 2021

• REC opinion

  Further Information Favourable Opinion