**The study is actively seeking new sites and would be happy to speak to any teams from a Multidisciplinary Diabetic Foot Unit.**

The CODIFI2 trial is a randomised controlled trial (RCT) comparing two wound sample collection techniques (swab and tissue sampling) in clinically infected diabetic foot ulcer (DFU) patients, with blinded outcome assessment, with 3 embedded Sub-studies

  • Population: Patient with DFU with suspected infection
  • Intervention: Tissue sampling
  • Comparator: Swab sampling
  • Outcome: Time to healing of index ulcer

A total of 730 eligible and consenting participants will be randomised in a 1:1 allocation ratio to either swab or tissue sampling from randomisation to the end of the interventional period (defined as randomisation to a minimum of week 52 and maximum week 104 post randomisation.

  • The primary outcome measure: Time to healing of index ulcer: Time from randomisation to healing of index ulcer (up to maximum follow-up of 104 weeks).
    • Sub-study 1: Embedded cross-sectional study comparing the agreement in detection of the presence of pathogens using molecular verses standard culture processing techniques.
    • Sub-Study 2: The value of information analysis will inform the potential value of future research about the choice of sample processing method (molecular verses standard culture processing techniques).

Contact details: Rachael Gilberts, Senior Trial Manager or Stephanie Kuunal, Trial Coordinator
CTRU-CODIFI2@leeds.ac.uk