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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetic Foot Infections Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Sacré-Cœur de Montréal, Montreal, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Diagnostic accuracy of 18F-FDG PET/CT for diabetic foot osteomyelitis

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gad Abikhzer, MD

CONTACT

[email protected]

514-340-8222

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Collaborators

Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Sep 18, 2026
Registry last updated: Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting