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NCT02165579 · ClinicalTrials.gov registry record
Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 36
- Enrollment target
NCT02165579: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT02165579 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165579 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER 1 cohort, standard care, observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-12 |
What the finished NCT02165579 record still lists
NCT02165579 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which 1 cohort, standard care, observational is the first listed.
NCT02165579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02165579 about?
NCT02165579 is a clinical study titled "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 spec...
What is the current status of trial NCT02165579?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2014-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02165579?
The interventions under investigation include: 1 cohort, standard care, observational (OTHER).
Who is sponsoring clinical trial NCT02165579?
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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