Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

Recruiting now · Not applicable

Conditions studied: Subjects With Diabetes and DFU With a Suspicion of DFO

In brief

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 their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive. To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO

Key facts

Study ID: NCT06066801
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 320
Starts: 2024-03-14
Expected to finish: 2027-10-01
Last updated by the study team: 2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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

You may not qualify 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
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 it is running

Bichat - Claude Bernard Hospital — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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