Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 80
Inclusion Criteria
- Infectious Disease Society of America stage 3 infection
- Age ≥ 21 years
- Diagnosis of diabetes mellitus
- Infectious Disease Society of America stage 3 infection
- Age ≥ 21 years
- Diagnosis of diabetes mellitus
Exclusion Criteria
- History of previous bone infection in the study foot
- HIV, Hepatitis, osteomyelitis at other sites
- Unable to provide informed consent
- History of previous bone infection in the study foot
- HIV, Hepatitis, osteomyelitis at other sites
- Unable to provide informed consent
Summary
- Conditions
- Diabetes
- Foot Ulcer
- Osteomyelitis
- Type
- Observational
- Design
- Observational Model: Case-Only
- Time Perspective: Prospective
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
There is a world-wide epidemic of diabetes. As part of the epidemic lower extremity amputations are dramatically increasing. Soft tissue and bone infections are one of the most common reasons for amputation. It is often difficult to determine if diabetic foot ulcers have an underlying bone infection...
There is a world-wide epidemic of diabetes. As part of the epidemic lower extremity amputations are dramatically increasing. Soft tissue and bone infections are one of the most common reasons for amputation. It is often difficult to determine if diabetic foot ulcers have an underlying bone infection. Inaccurate diagnosis of osteomyelitis leads to unnecessary antibiotic treatment, surgery, and amputation. In addition, we do not have good diagnostic tools to determine when osteomyelitis has been treated successfully. The role of biomarkers specific to bone turnover (resorption and formation) in relation to bone infections is poorly understood. We know that remodeling is an essential function in bone physiology with increased osteoclast production leading to resorption of old bone coupled with increased osteoblast production associated with new bone formation. The balance between these two functions is known to be disrupted in disease states including osteoporosis, but has not been examined specifically in infected bone. Procalcitonin has been suggeasted as a tool to both diagnose and monitor the effectiveness of therapy for various infections, but there is very little work in diabetic foot osteomyelitis. Aim 1. To evaluate the role of procalcitonin as a screening tool to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis. Aim 2. To determine the role of procalcitonin as a management tool to determine osteomyelitis treatment success versus treatment failure (indicated by bone biopsy) after completing a standard course of antibiotics for 6 weeks.
Inclusion Criteria
- Infectious Disease Society of America stage 3 infection
- Age ≥ 21 years
- Diagnosis of diabetes mellitus
- Infectious Disease Society of America stage 3 infection
- Age ≥ 21 years
- Diagnosis of diabetes mellitus
Exclusion Criteria
- History of previous bone infection in the study foot
- HIV, Hepatitis, osteomyelitis at other sites
- Unable to provide informed consent
- History of previous bone infection in the study foot
- HIV, Hepatitis, osteomyelitis at other sites
- Unable to provide informed consent
Tracking Information
- NCT #
- NCT02165579
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lawrence Lavery UT Southwestern Medical Center
- Lawrence Lavery UT Southwestern Medical Center
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