Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with diabetes and a foot wound where a bone infection (osteomyelitis) is suspected. It compares a bone sample taken at the bedside with the standard way of taking it.

Életkor

Over 18 years

Nem

All sexes

A betegség stádiuma

Diabetic foot with at least one sign of bone infection: a positive probe-to-bone test with X-ray changes, or signs on CT, MRI, white blood cell SPECT/CT or FDG-PET/CT scan.

Korábbi kezelés

No antibacterial treatment in the 14 days before joining. No antibiotic treatment in the last 15 days before the bone sample.

A részvétel fő kizáró okai

• Urgent need for surgery
• Severe lack of blood flow to the leg that cannot be fixed by a procedure to restore blood flow
• Bone infection in the area of a Charcot foot
• Not expected to live at least 1 year
• Pregnant or breastfeeding women; no French social insurance or only State medical aid (AME)

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Bedside blind bone biopsy procedureA vizsgált kezelés

  Bedside blind bone biopsy procedure performed by a physician of the participating center through healthy skin with bone trocar following local and light systemic anesthesia. Samples will be analyzed for microbiology and histopathology

• Standard bone biopsy procedureMár használt kezelés, összehasonlításként

  Standard BB procedure (surgical or radiological) performed according to the local standard of care of each participating center and done through healthy skin and under locoregional anesthesia. Samples will be analyzed for microbiology and histopathology

  Kezelés: Bedside blind bone biopsy procedure