Osteomyelitis in diabetes with foot ulcer Nutritional, Metabolic, Endocrine Osteomyelitis in diabetes with foot ulcer
Conditions
Interventions
DOMINO-DFU is a multi-centre cohort study of new referrals with a diabetic foot ulcer (DFU) to secondary care MDT diabetic foot ulcer clinics. A sub-cohort with clinical features at high-risk of diabe
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Full clinical cohort: 1. Aged 18 years or over 2. Diagnosed with diabetes mellitus (according to WHO criteria) 3. New active diabetic foot ulcer, as defined by a wound below the malleoli in a person with diabetes 4. Consent to participate (written/witnessed verbal informed consent) High-risk clinical cohorts: 1. Exhibit one of the following high-risk features for DFO: 1.1. Clinical infection (IDSA criteria) + positive Probe to Bone (PTB); or 1.2. Ulcer with area =2 cm²; or 1.3. Ulcer PTB or 1.4. Ulcer depth =3 mm; or 1.5. Dactylitis; or 1.6. “Hard-to-heal” as defined by failure to heal by >50% in the previous 4 weeks High-risk phase 2 diagnostic concordance study cohort: 1. Provide second-level consent for both ‘through-the-ulcer’ and ‘remote’ bone biopsies
Exclusion criteria
Exclusion criteria: 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 biopsies 2. Would not be ethically appropriate to approach the patient e.g. on end of life care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical diagnosis of diabetic foot osteomyelitis (DFO) over 52 weeks from baseline collected from clinical notes (full cohort) 2. Standard care for DFO over 12 months collected from clinical notes (Phase 1) 3. Antibiotic use over 12 months collected from clinical notes (Phase 1) 4. Presence and subtype of histological evidence of DFO from bone sample taken at baseline (Phase 2) 5. Presence and number of pathogens per bone sample collected at baseline (Phase 2) 6. Clinical diagnosis of DFO over 52 weeks from baseline collected from clinical notes (Phase 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Healing status at 12, 24, and 52 weeks measured as complete re-epithelisation without discharge, maintained for 2 weeks 2. Mortality over 52 weeks from baseline from clinical notes 3. Ulcer recurrence over 52 weeks from baseline from clinical notes 4. Recurrence of DFO over 52 weeks from baseline from clinical notes 5. Outcome of DFO at 12, 24, and 52 weeks (resolution, relapse, remission, need for surgery) from clinical notes 6. Adverse events over 52 weeks from baseline (new infection, hospitalisation, amputation) from clinical notes 7. Health-related quality of life using the Diabetic Foot Scale –Short Form (DFS-SF) and EQ-5D-5L at baseline, 4, 12, 24, and 52 weeks 8. Cost effectiveness using Health resource utilisation using questionnaires at baseline, 4, 8, 12, 24, and 52 weeks 9. Therapeutic yield for current DFO diagnostic practice (Phase 1) from clinical notes 10. Diagnostic yield for bone samples taken at baseline (Phase 2) 11. Patient-reported pain scores (none, mild, moderate, severe) for bone sampling at baseline (Phase 2) 12. Bone sample complications (bleeding, infection, fracture, Charcot) over 52 weeks from baseline (Phase 2 and 3) 13. Diagnostic and therapeutic yield of optimal diagnostic prediction model (Phase 3) | — |
Countries
England, United Kingdom
Outcome results
None listed