The main objective of the proposed research study is to determine the potential utilization of \[18-F\] Fluorodeoxyglucose (FDG) positron emission tomography (PET) in patients with complicated diabetic foot, especially in the diagnosis or exclusion of osteomyelitis in this setting. We intend to validate and establish the necessary criteria for making such a diagnosis and determine the accuracy of the technique through comparison with other existing modalities, including MRI, and patient outcome. We expect that at the completion of the proposed research, the role of these powerful imaging modalities will be clearly defined in the management of patients with this challenging and serious complication.
Who can participate
Age range
18 Years
Sex
ALL
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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 evalua…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.