Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/10/2018 |
| Start Date: | June 2014 |
| End Date: | December 2014 |
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.
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.
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.
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:
- Diagnosis of diabetes mellitus
- Age ≥ 21 years
- Infectious Disease Society of America stage 3 infection
Exclusion Criteria:
- History of previous bone infection in the study foot
- Unable to provide informed consent
- HIV, Hepatitis, osteomyelitis at other sites
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