Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06327113

Antibiotic Tumescent For Chronic Wounds

Led by University of California, Los Angeles · Updated on 2026-04-23

60

Participants Needed

1

Research Sites

209 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Antibiotic Tumescent For Chronic Wounds

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18 years of age or older
  • Presence of one or more full thickness ulcers on lower extremity, upper extremity (excluding hands), or trunk with surface area >0.5 cm² and <30 cm² after debridement
  • Chronic wound present for more than 4 weeks at first visit
  • Wound treated at least twice at a wound care center
  • Wound area has not decreased by more than 50% in 4 weeks
  • Adequate blood flow to the affected area as demonstrated by specific measurements or palpable pulses
  • Ability and willingness to provide written informed consent and comply with study requirements
  • For those able to have children, use of two forms of contraception (one must be a barrier method) between visits 1-4
Not Eligible

You will not qualify if you...

  • Limb-threatening infection or extensive cellulitis extending 2 cm or more beyond wound borders
  • Presence of lymphangitis, fasciitis, deep tissue infection, abscess, pus, or osteomyelitis
  • Wound size, duration, severity, or location outside inclusion criteria
  • Clinically severe wound at high risk for amputation
  • Pressure ulcers except those below the knee
  • Acute infection signs such as significant redness, warmth, pus, tenderness beyond 2 cm from wound edge or fever >100.4°F
  • Positive wound culture for Pseudomonas after enrollment
  • Symptoms of systemic infection or uncontrolled diabetes mellitus
  • Allergy or hypersensitivity to penicillin, cefazolin, beta-lactams, cephalosporins, lidocaine, or similar anesthetics
  • Need for intravenous antibiotics during study (except mild localized infections approved by Medical Director)
  • Current dialysis treatment, awaiting dialysis, or low kidney function (eGFR ≤ 30 mL/min/1.73 m²)
  • Expected inability to care for ulcer during study period
  • Active alcohol or substance abuse within 6 months before study entry
  • Use of systemic corticosteroids (≥20 mg prednisone/day), biologic therapy, immunosuppressants, radiation, or cytotoxic agents unless approved
  • Current treatment for primary or metastatic cancer (except specific skin cancers not involving wound site)
  • AIDS or known HIV positive status
  • Any other condition judged by investigator to risk safety or interfere with study
  • Women who are breastfeeding, pregnant, or trying to become pregnant
  • Medically unstable conditions including high A1C (>9.5), unstable cardiovascular or general health, severe metabolic or organ disorders, recent trauma with severe damage, or sickle cell disease
  • Participation in another clinical study or refusal to avoid other studies during this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

A

Andrew Vardanian, MD

CONTACT

M

Marco Morcos

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Antibiotic Tumescent For Chronic Wounds | DecenTrialz