Status:
ACTIVE_NOT_RECRUITING
FDG-PET Imaging in Complicated Diabetic Foot
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Diabetic Foot Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 diabeti...
Detailed Description
FDG-PET imaging is a promising imaging technique, which has the potential to overcome many of the shortcomings mentioned previously with regard to radiologic and scintigraphic methodologies. FDG is a ...
Eligibility Criteria
Inclusion
- 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
- Patients with complications of the foot with etiologies not related to diabetes will be excluded from this study.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00194298
Start Date
October 1 2002
End Date
February 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104