An observational study in Diabetic Foot Infections, sponsored by Jewish General Hospital. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Jewish General Hospital · Observational
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Jewish General Hospital is the lead sponsor of 97 studies on the registry; 11 are open to participants now.
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Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who have been referred by their treating physician for 18F-FDG PET/CT at participating academic centers in Canada and the United States. Approximately 150 consecutive eligible participants will be prospectively enrolled. Clinical care, including the decision to perform bone biopsy or other investigations and treatments, will remain at the discretion of the treating physicians.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 or undergo PET/CT imaging
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: 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.
Diagnostic accuracy of 18F-FDG PET/CT for diabetic foot osteomyelitis
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.
Time frame: At least 6 months after PET/CT
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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