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

NCT07828691 — Not yet recruiting, 150 participants, Jewish General Hospital

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18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis: A Prospective Multicenter Study of Diagnostic Accuracy

Registry	NCT07828691
Status	Not yet recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Jewish General Hospital (Other); collaborators: Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund
Conditions	Diabetic Foot Infections
Interventions	18F-FDG PET/CT (Diagnostic test)
Dates	start 2026-11-01 (estimated), primary completion 2028-12-01 (estimated), completion 2029-04-01 (estimated), first posted 2026-09-18, last updated 2026-09-18
Locations	4 sites in United States, Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with suspected diabetic foot osteomyelitis		Diagnostic Test: 18F-FDG PET/CT	Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who are referred by their treating physician for 18F-FDG PET/CT. Participants will undergo standard clinical care and will be followed through medical record review for at least 6 months to establish the final diagnosis and clinical outcomes.

18F-FDG PET/CT (Diagnostic test): 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Age ≥18 years Diagnosis of diabetes mellitus Referred by the treating physician for clinically indicated 18F-FDG PET/CT of the foot for diabetic foot infection with concern for possible osteomyelitis

Exclusion Criteria:

History of previous bone infection in the study foot within the past 6 months Congenital bone disease such as osteogenesis imperfecta Active pregnancy Recent surgery in the foot with suspected osteomyelitis within the past 6 months Inability to provide informed consent or undergo PET/CT imaging

+Locations (4)

Facility	City	Country
UT Southwestern Medical Center	Dallas, Texas	United States
Hôpital du Sacré-Cœur de Montréal	Montreal	Canada
Jewish General Hospital	Montreal	Canada
McGill University Health Centre	Montreal	Canada