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Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06066801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and the

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📋 Eligibility rules (as published)
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 * Osteomyelitis in the area of the Charcot foot destructive process * 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
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What it tests

  • Bedside blind bone biopsy procedure
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Where

1 site
Bichat - Claude Bernard Hospital
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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