Randomised controlled trial of swab vs tissue sampling for infected diabetic foot ulcers

Trial Design: Multi-centre, phase III, parallel group, randomised controlled trial in diabetic foot ulcer infection (DFU), including a 12month internal pilot phase (study 1) & study 2: diagnostic technique agreement study, virtual clinic study, prognostic model development, qualitative study and value of information analysis Setting. Sub-study 2:Processing Techniques - A primary sample sent for routine culture and sensitivity testing. A second wound sample (swab in those allocated to swab sampling at randomisation; tissue from those allocated to tissue sampling) sent to central laboratory for molecular testing, thus we will have both swab and tissue samples with analysis by molecular methods and culture. Aim to assess concordance between microbiology results obtained via C&S and molecular methods.