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NCT06327113 · ClinicalTrials.gov registry record · Phase 2
Antibiotic Tumescent For Chronic Wounds
A Phase 2 study of Non-healing Wound, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06327113: Recruiting Phase 2 study of Non-healing Wound, sponsored by University of California, Los Angeles.
NCT06327113 is a Phase 2 study of Non-healing Wound that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 60 participants, below the 211-participant average among 3 other Non-healing Wound trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06327113, a Phase 2 study of Non-healing Wound, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.
Primary Outcome
Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, and the relationship to TAI. The severity of adverse events will be measured by the adverse event severity scale (1-4; Mild; Moderate; Severe; Life-threatening). The relationship of the adverse event to the study drug will be assessed by the likelihood of the relationship (Definitely; Probably; Possibly; Unrelated). Frequency of adverse events that
Conditions Studied
Interventions
- DRUG CeFAZolin Injectable Solution
Study Locations (1)
California
- University of California, Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-17 |
| Est. Completion | 2028-05-25 |
| Phase | Phase 2 |
What NCT06327113 shows while recruiting
NCT06327113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 211-participant average among 3 other Non-healing Wound trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Non-healing Wound appearing as the primary indexed condition, and to 1 intervention - of which CeFAZolin Injectable Solution is the first listed.
NCT06327113 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06327113 about?
NCT06327113 is a clinical study titled "Antibiotic Tumescent For Chronic Wounds". Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution wi...
What is the current status of trial NCT06327113?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-05-17. Estimated completion is 2028-05-25.
What conditions does trial NCT06327113 study?
This clinical trial studies the following conditions: Non-healing Wound.
What interventions are being tested in trial NCT06327113?
The interventions under investigation include: CeFAZolin Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT06327113?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06327113 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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