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NCT04025853 · ClinicalTrials.gov registry record
Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 455
- Enrollment target
NCT04025853: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT04025853 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 455 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04025853 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 455 participants
- Enrollment target
Study Summary
The investigators plan to do a retrospective chart review of 500 patients admitted to the hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. The investigators will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis. Levels of inflammatory biomarkers (CRP, ESR) will be collected from the charts from the first time of diagnosis. Because wound healing, biomarker levels and resolution of infection are clearly affected by other factors such as demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement and vascular surgery interventions these will also be collected. The investigators will collect this clinical data for both cohorts.
Primary Outcome
To correlate the level of white blood cell count, c-reactive protein and erythrocyte sedimentation rate with the results of bone culture and histopathology as the "gold standard" to establish the diagnosis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-03 |
What the finished NCT04025853 record still lists
NCT04025853 is an observational study that tracks outcomes without assigning an intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04025853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04025853 about?
NCT04025853 is a clinical study titled "Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis". The investigators plan to do a retrospective chart review of 500 patients admitted to the hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. The investigators will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic findin...
What is the current status of trial NCT04025853?
This trial is currently completed. The enrollment target is 455 participants. The study started on 2015-06. Estimated completion is 2018-03.
Who is sponsoring clinical trial NCT04025853?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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