Clinical Trial: Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis (PCT)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

Brief Summary: We plan a cohort study of 40 diabetic patients admitted to Parkland hospital with a foot infection. We will enroll a representative cross section of subjects with diabetic foot infection. Patient will be consented and will receive therapy based on standard protocols. Currently patients with suspected osteomyelitis have bone biopsies to identify bacterial pathogens and verify MRI diagnosis. Repeat bone biopsies are performed at the end of therapy to verify that osteomyelitis has been successfully treated. Serum to measure procalcitonin will be obtained at baseline, week 3 and week 6.

Detailed Summary:

Infection: will be defined as a patient with three of six clinical signs of infection (erythema, heat, edema, pain, loss of function, purulence) or leukocytosis. We will use the Infectious Diseases Society of America's Diabetic Foot Infection guidelines to stratify the severity of infection. This guideline stratifies infections into three categories (mild, moderate, and severe) based on practical clinical and laboratory findings. Our group has shown this system to be predictive of morbidity.

Osteomyelitis Diagnosis: We will evaluate suspected cases of osteomyelitis with bone biopsy for histology and culture and sensitivity. Bone biopsy to diagnose osteomyelitis is part of the standards of care established from the "diabetic foot infection guidelines" in our institution. We expect 1/4 of patients will have negative bone biopsy results. We will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute osteomyelitis or chronic osteomyelitis. Acute osteomyelitis will be defined as the presence of acute inflammatory cells, congestion or thrombosis of medullary or periosteal small vessels, and necrotic bone. Chronic osteomyelitis will demonstrate areas of woven bone and fibrosis with large numbers of lymphocytes, histiocytes, and plasma cells.

Outcome Measures: Our primary endpoints will be resolution of osteomyelitis based on percutaneous bone biopsy six weeks after initiation of therapy. We will evaluate patients for six months for signs of recurrent osteomyelitis and other clinical outcomes (wounds, Charcot fracture, and infection). Clinical outcomes will include (1.) wound healing, (2.) limb salvage, (3.) hospitalizations for recurrent diabetic foot infection (4.) surgical procedures, and (5.) recurrent ulcers.

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Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: The primary endpoints will be changes in procalcitonin levels at Baseline, Week 3 and Week 6 correlated with resolution of osteomyelitis based on percutaneous bone biopsy six weeks after initiation of therapy. [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: November 7, 2014
Date Started: August 2014
Date Completion:
Last Updated: December 11, 2015
Last Verified: December 2015