FDG-PET Imaging in Complicated Diabetic Foot

NCT00194298 | Active Not Recruiting

• 1 other identifier: R01DK063579-04
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetic Foot Disease

Keywords

diabetic foot disease; osteomyelitis; charcot; neuropathy; hypoxia; [18 F] Fluorodeoxyglucose; Positron Emission Tomography Imaging

Outcome Measures

Primary Outcomes (1)

• SUV measurement from PET scan

  Standardized Uptake Value

  Following completion of PET scan

Interventions

FDG-PET Imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• Patients with complications of the foot with etiologies not related to diabetes will be excluded from this study.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteomyelitis; Hypoxia

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abass Alavi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2002
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)