18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis

Condition(s) studied

Investigational drug(s) / intervention(s)

18F-FDG PET/CT: 18F-FDG PET/CT of the feet performed using current-generation digital PET/CT systems and a standardized acquisition protocol. PET/CT images will subsequently be evaluated using standardized interpretation criteria to determine diagnostic performance for diabetic foot osteomyelitis.

Study summary

Diabetic foot osteomyelitis (DFO) is a bone infection of the foot that can occur in people with diabetes and may lead to serious complications, including amputation. Diagnosing DFO can be difficult. This prospective multicenter observational study will evaluate how accurately 18F-FDG PET/CT can diagnose DFO in patients who are already referred for this imaging test as part of their clinical care. The study will use current-generation digital PET/CT systems and standardized interpretation criteria. PET/CT findings will be compared with bone biopsy results when available, or with clinical and imaging findings obtained during at least 6 months of follow-up.

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy of 18F-FDG PET/CT for diabetic foot osteomyelitis — At least 6 months after PET/CT
  Diagnostic performance of 18F-FDG PET/CT for diabetic foot osteomyelitis will be assessed by calculating sensitivity, specificity, positive predictive value, and negative predictive value. PET/CT findings will be compared with a reference standard consisting of histopathology from bone biopsy when available, unequivocal cortical erosion/destruction on CT, or clinical and radiographic/CT confirmation during follow-up.

Trial sites (4)

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