Could a quick bedside biopsy replace the standard for diabetic foot infections?
NCT ID NCT06066801
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a bedside bone biopsy, done in the patient's room, works as well as the usual surgical or radiology-guided biopsy to diagnose bone infection in diabetic foot ulcers. The trial will include 320 adults with diabetes and signs of foot bone infection. If the bedside method proves non-inferior, it could offer a simpler, faster way to guide antibiotic treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bedside blind bone biopsy procedure
- What this could lead to
- If successful, this could make diagnosing bone infections in diabetic foot ulcers simpler and more accessible, potentially reducing delays in treatment.
- What could go wrong
- This is a non-inferiority trial testing a procedure already used in practice, so it may not show a major improvement. The bedside method might be less accurate than the standard approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bichat - Claude Bernard Hospital
RECRUITINGParis, 75018, France
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