Status:
RECRUITING
Bedside Bone Biopsy in Diabetic Foot Osteomyelitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Subjects With Diabetes and DFU With a Suspicion of DFO
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-t...
Detailed Description
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 disease1. DFU is the leading cause of non-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06066801
Start Date
March 14 2024
End Date
October 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
Bichat - Claude Bernard Hospital
Paris, France, 75018