Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criterias

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

Exclusion Criterias

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

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 Criterias

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

Exclusion Criterias

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

Locations

Dallas, Texas, 75390-9132
Dallas, Texas, 75390-9132

Tracking Information

NCT #
NCT02165579
Collaborators
Not Provided
Investigators
  • Principal Investigator: Lawrence Lavery UT Southwestern Medical Center
  • Lawrence Lavery UT Southwestern Medical Center