Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis (PCT)

NCT02308774 | Completed

• 1 other identifier: 022014-007
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

We plan a cohort study of 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.

Conditions

Osteomyelitis

Keywords

osteomyelitis, diabetic foot infection

Outcome Measures

Primary Outcomes (1)

• The primary endpoints will be changes in procalcitonin levels at Baseline, Week 3 and Week 6 correlated with resolution of osteomyelitis based on percutaneous bone biopsy six weeks after initiation of therapy.

  Serial measurements of procalcitonin at Baseline, Week 3 and Week 6.

  6 weeks

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be identified from the investigator's inpatient and outpatient populations. This is not a treatment study, so subjects participating in other protocols will also be eligible to participate.

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and tissue samples

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lawrence A Lavery, DPM, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: December 4, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)