Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

Completed

Conditions studied: Diabetes, Foot Ulcer, Osteomyelitis

In brief

The investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic foot infection in order to compare serial bone biopsies (the current "gold standard") and procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. The investigator will collect specimens as part of an existing trial to evaluate negative pressure wound therapy in diabetic infected wounds. A high proportion of these patients have osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral antibiotics. The investigator expects repeated measurement of procalcitonin will be highly correlated with repeated bone biopsy after antibiotic treatment has been completed to determine if therapy has been successful or if additional antibiotic therapy is needed.

Key facts

Study ID

NCT02165579

Run by

University of Texas Southwestern Medical Center

People needed

36

Starts

2014-06-01

Expected to finish

2014-12-01

Last updated by the study team

2018-06-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus
• Age ≥ 21 years
• Infectious Disease Society of America stage 3 infection

You may not qualify if…

• History of previous bone infection in the study foot
• Unable to provide informed consent
• HIV, Hepatitis, osteomyelitis at other sites

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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