Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

NCT02165579 | Completed

• 1 other identifier: Biomarkers for Osteomyelitis
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Foot Ulcer; Osteomyelitis

Keywords

procalcitonin; biomarkers; Osteomyelitis; diabetes; foot ulcer(s); Infectious Disease Society of America stage 3 infection

Outcome Measures

Primary Outcomes (1)

• (1.) wound healing,

  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.

  6 months

Secondary Outcomes (4)

• (2.) limb salvage

  6 months

• (3.) hospitalizations for recurrent diabetic foot infection

  6 months

• (4.) surgical procedures

  6 months

• (5.) recurrent ulcers.

  6 months

Study Arms (1)

Age > 21, diabetes, osteomyelitis

1 Cohort, standard care, observational patients are: Diagnosis of diabetes mellitus Age ≥ 21 years Infectious Disease Society of America stage 3 infection

Other: 1 cohort, standard care, observational

Interventions

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.

Age > 21, diabetes, osteomyelitis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age \> 21, diabetes, Infectious Disease Society of America stage 3 infection (osteomyelitis)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Osteomyelitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lawrence Lavery

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

US (1)