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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Jewish General Hospital
Study ID
NCT07828691
Status
Not Yet Recruiting

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Conditions

  • Diabetic Foot Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Diagnostic accuracy of 18F-FDG PET/CT for diabetic foot osteomyelitis [ Time Frame: At least 6 months after PET/CT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

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UT Southwestern Medical Center· Dallas, TX