New scan could spot hidden bone infections in diabetic feet

NCT ID NCT00194298

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First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study looks at whether a special type of PET scan (FDG-PET) can more accurately detect bone infections (osteomyelitis) in people with diabetic foot disease. Researchers will compare the scan results with MRI and follow patient outcomes to see how well it works. The goal is to improve diagnosis and guide treatment for this serious complication.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Oct 2002

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

240 patients selected for entry into this study will be men or women of any ethnic background diagnosed with diabetic foot disease and/or patients with diabetes and suspected infection(s) below the hip by members of the Diabetes Center of the Department of Medicine, the Division of Vascular Surgery of the Department of Surgery at the University of Pennsylvania Health System (Hospital of the University of Pennsylvania), the Ankle and Foot Medical Centers of Delaware Valley (PENN Presbyterian Hospital, and the Pennsylvania Orthopedic Foot and Ankle Surgeons (Pennsylvania Hospital).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The 240 patients selected for entry into this study will be men or women of any ethnic background diagnosed with diabetic foot disease by members of the team in the Diabetes Center of the Department of Medicine and the division of Vascular Surgery of the department of Surgery at the University of Pennsylvania Health System (Hospital of the University of Pennsylvania). Study I: FDG-PET imaging of patients with diabetic foot without clinical suspicion of osteomyelitis or deep-seated tissue infections The patients must have clinical diagnosis of uncomplicated diabetic foot. Each patient will undergo appropriate evaluation including history, physical examination, standard radiographic evaluation (including MRI), and grading of peripheral neuropathy using the Michigan Neuropathy Screening Instrument (MNSI). Patients will be divided into three groups, corresponding to MNSI score of 0-3, 4-8, and 9-13, which we will classify as mild, moderate, and severe, respectively. We intend to enroll 26 patients in each of the first two groups and 27 patients in the third. Study II: FDG-PET imaging of patients with diabetic foot and clinical suspicion of osteomyelitis or deep-seated infections The patients must have clinical diagnosis of complicated diabetic foot. These patients will be those suspected of having a deep-seated infection and may or may not be scheduled to undergo amputation or debridement of affected tissue. Each patient will undergo an appropriate evaluation including history, physical examination, radiologic examination including MRI, MNSI, and vascular assessment by segmental Doppler pressures and pulse wave recording. Exclusion Criteria: * Patients with complications of the foot with etiologies not related to diabetes will be excluded from this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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