Scan imaging to detect bone infection in the feet of people with diabetes
Tests how well 18F-FDG PET/CT finds bone infection in diabetic feet.
Key facts
- Who runs it
- Jewish General Hospital
- Where
- Dallas, United StatesSee the siteAlso in 1 other country, 3 sites
- Trial code
- Registry title
- 18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- Nov 2026
- Expected to end
- Apr 2029
- Type of study
- Observational
- Treatments tested
- 18F-FDG PET/CT
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetes who have a foot infection that may have spread to the bone. Their doctor must already have sent them for an 18F-FDG PET/CT scan of the foot.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Diabetic foot infection with concern for possible bone infection (osteomyelitis)
- Earlier treatment
- People who had surgery on the foot in question within the past 6 months cannot join.
Main reasons for not taking part
- A bone infection in the study foot within the past 6 months
- A bone disease present from birth, such as osteogenesis imperfecta
- Being pregnant
- Surgery on the foot with suspected bone infection within the past 6 months
- Not able to give informed consent or not able to have the PET/CT scan
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 1 other country, 3 sites
- UT Southwestern Medical CenterDallas, United StatesContact: Gad Abikhzer, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients with suspected diabetic foot osteomyelitis
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.
Treatment: 18F-FDG PET/CT
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis: A Prospective Multicenter Study of Diagnostic Accuracy
- Plain-language title
- Scan imaging to detect bone infection in the feet of people with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 18 September 2026