Bedside Bone Biopsy in Diabetic Foot Osteomyelitis (BOLBOC)
Subjects With Diabetes and DFU With a Suspicion of DFO
About this trial
This is an interventional diagnostic trial for Subjects With Diabetes and DFU With a Suspicion of DFO focused on measuring Bedside bone biopsy, conventional bone biopsy, diabetes, Diabetic Foot Ulcer (DFU), diabetic foot osteomyelitis (DFO)
Eligibility Criteria
Inclusion Criteria: Patients eligible for inclusion in this study must fulfill all of the following criteria: Aged >18 years Diabetes mellitus At least one of the following signs of osteomyelitis according to IWGDF 2019 guidelines: A positive probe to bone test and abnormalities on plain X-ray suggestive for osteomyelitis Signs of osteomyelitis on CT-scan and/or MRI and/or white blood cell SPECT/CT and/or FDG-PET/CT-scan - Absence of antibacterial therapy within 14 days before inclusion Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: Urgent need for surgery Critical limb ischemia which cannot be corrected by revascularization procedure Subjects that (are likely to) undergo surgical or percutaneous revascularization are not excluded Antibiotic treatment in the last 15 days before bone biopsy Diabetic charcot foot Unlikely to live at least 1 year Not being able to give informed consent and willing to comply with the research protocol Pregnant or breastfeeding women Absence of affiliation to French social insurance State medical aid (AME) Deprivation of liberty, being under a legal protective measure
Sites / Locations
- Bichat - Claude Bernard Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bedside blind bone biopsy procedure
Standard bone biopsy procedure
Bedside blind bone biopsy procedure performed by a physician of the participating center through healthy skin with bone trocar following local and light systemic anesthesia. Samples will be analyzed for microbiology and histopathology
Standard BB procedure (surgical or radiological) performed according to the local standard of care of each participating center and done through healthy skin and under locoregional anesthesia. Samples will be analyzed for microbiology and histopathology