Osteomyelitis of the foot in diabetes Musculoskeletal Diseases osteomyelitis
Conditions
Interventions
Patients will be randomised to two groups. The first will have a bone biposy, the culture of which will allow the investigators to target the antibiotics given. The second group will not be biopsied b
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 1 or type 2 diabetes mellitus 2. Aged greater than or equal to 18 years, either sex 3. Previously undiagnosed infection of bone in the foot (excluding disease limited to the tibia and or fibula), which is either definite or strongly suspected on clinical grounds 4. Able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Critical ischaemia: clinical or other criteria which suggest to the managing clinician that bone biopsy is relatively contraindicated 2. Frailty or disability which would mean that participation in the study might have an adverse effect on patient well being and mood 3. Pregnancy or the possibility of the occurrence of pregnancy during the study period 4. Those who are unwilling or unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence at six months of apparent arrest of bone infection without amputation, measured at six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and level of amputation (major or minor) 2. Survival: death related directly or not to infection of the foot 3. Incidence of reactivated or recurrent infection 4. Prevalence of active ulceration (persistent, reactivated or recurrent) at the end of the study 5. Days in hospital (for reasons both related or not to the infection) 6. Complications of bone biopsy 7. Adjustment of chosen antibiotic regimen 8. Duration of antibiotic treatment (intravenous and oral) 9. Infection or colonisation after the initiation of antibiotic treatment of ulcers on either foot (or other clinical infections) with MRSA and/or multiresistant organisms (MDROs): bacteria that are resistant to antibiotics which are typically used in their treatment, e.g., MRSA, vancomycin-resistant enterococci (VRE), or extended-spectrum beta lactamases (ESBL) producing gram-negative bacilli 10. Other superinfections, side-effects and adverse events (including C. difficile diarrhoea) occurring at any stage in the period of follow-up 11. Comparison of the results of baseline microbiological sampling from superficial soft tissue, deep soft tissue and bone 12. Measurement of health outcome, by results of EuroQoL instrument (EQ-5D) at 6 and 12 months after randomisation, and change from baseline Outcomes will be measured at six months. | — |
Countries
France, Germany, Italy, Sweden, United Kingdom
Outcome results
None listed