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Antibiotic Tumescent For Chronic Wounds

Study acronym: TAI
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv4
  2. Minor Eligibility criteria expanded, about 27 wordsv3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Mar 25, 2027 to May 25, 2027
    • Study completion date: Mar 25, 2028 to May 25, 2028
    • Start date changed from estimate of Mar 25, 2024 to May 17, 2024
    • Study description expanded, about 1 word
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06327113
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Non-healing Wound
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov