Bedside bone biopsy for diabetic foot osteomyelitis
Bedside Bone Biopsy Versus Conventional Bone Biopsy for Management of Diabetic Foot Osteomyelitis: an Open-label Controlled Randomized Non-inferiority Trial
This study is testing a simpler and less invasive bedside procedure to see if it can help diagnose bone infections in people with diabetic foot ulcers more quickly and accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06066801 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a bedside blind bone biopsy procedure for diagnosing diabetic foot osteomyelitis (DFO) in patients with diabetic foot ulcers (DFU). DFO complicates a significant number of DFUs and is a leading cause of amputations among diabetic patients. The study aims to improve early diagnosis and appropriate antimicrobial treatment by utilizing a less invasive biopsy method performed directly at the bedside. This approach seeks to overcome barriers associated with traditional biopsy methods, which are often underused due to cost and complexity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with diabetes mellitus who show signs of osteomyelitis.
Not a fit: Patients with urgent surgical needs, critical limb ischemia, or those who have received antibiotic treatment in the last 14 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of DFO, potentially reducing the need for amputations and improving patient quality of life.
How similar studies have performed: While traditional bone biopsy methods have been established, this bedside approach is relatively novel and has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Paris
- Bichat - Claude Bernard Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Louis Potier, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Louis Potier, MD, PhD
- Email: louis.potier@aphp.fr
- Phone: 01 40 25 88 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.