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NCT Number: NCT02165579

Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

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.

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Key information

Conditions

Diabetes Bone Diseases Bone Diseases, Infectious Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Infections Leg Ulcer Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteomyelitis Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 cohort, standard care, observational

Other

This is one cohort standard care observational study. 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. Tissue samples will be obtained at Baseline, Week 3 and Week 6 for tissue culture.

Primary outcomes

  1. (1.) wound healing,

    Time frame: 6 months

    Clinical examination. Per current standards, wound healing will be defined as complete granulation over the wound bed (primary intention) or wounds closed by surgical intervention. 80 subjects will be followed during the course of the study and the wound healing dates recorded for those subjects who heal.

Secondary outcomes

  1. (2.) limb salvage

    Time frame: 6 months

    Clinical examination. This outcome will be measured by the number of subjects not requiring amputation during the time frame of the study.

  2. (3.) hospitalizations for recurrent diabetic foot infection

    Time frame: 6 months

    The medical record will be reviewed on each subject and dates of hospitalizations for diabetic foot infection will be recorded.

  3. (4.) surgical procedures

    Time frame: 6 months

    The medical record will be reviewed for each subject, and the dates and surgical procedures will be recorded.

  4. (5.) recurrent ulcers.

    Time frame: 6 months

    The medical record will be reviewed for each subject and any recurrence of diabetic foot ulcers during the time frame of the study will be recorded. Data will include the date(s) of recurrence, location and size of the ulcer(s), and the presence or absence of infection.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2014
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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