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New treatment option for Subjects With Diabetes and DFU With a Suspicion of DFO
Official title Bedside Bone Biopsy in Diabetic Foot Osteomyelitis
ClinicalTrials.gov ID: NCT06066801
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
- people 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
See the full eligibility 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...
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.