Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06327113

A Phase 2 Randomized Study Comparing Subcutaneous Tumescent Antibiotic Administration With Standard of Care for the Treatment of Chronic Wounds

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

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic non-healing wounds, such as diabetic foot ulcers, venous ulcers, and pressure ulcers, are a growing problem affecting millions worldwide and contributing significantly to healthcare costs. This trial evaluates a new approach using tumescent antibiotic injections (TAI) to deliver antibiotics directly around chronic wounds, aiming to improve healing by targeting bacteria locally while minimizing systemic side effects. The study is a Phase 2 randomized trial comparing TAI combined with standard wound care to standard wound care alone. Participants will be randomly assigned to either continue with standard wound care alone or receive a one-time tumescent antibiotic injection along with standard care. The antibiotic used is Cefazolin injected around the wound area. The treatment day involves delivering this injection, while standard wound care continues as usual for all participants. The study includes a screening period of up to one week and follow-up visits over six months, with scheduled assessments to monitor wound healing and safety. Participants will attend about six study-specific visits over approximately six months, which may coincide with regular wound care visits. During these visits, wound size and healing progress will be documented, and patients will complete surveys on pain and quality of life. Researchers will monitor safety by assessing adverse events related to the antibiotic injection and evaluate wound closure, pain levels, and quality of life. The total participant involvement may last up to one year including follow-up, with the study aiming to conclude within two years overall.

CONDITIONS

Brief 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
  • Having one or more full thickness ulcers on the lower extremity, upper extremity (excluding the hands), or trunk with a surface area between 0.5 cm² and 30 cm² after debridement
  • Presence of a chronic wound lasting more than 4 weeks at first visit
  • Wound has been treated at least twice at a wound care center
  • Wound area has not decreased by more than 50% in 4 weeks
  • Able and willing to provide written informed consent and comply with study requirements
  • Adequate blood flow to the affected area as demonstrated by specific blood pressure or pulse measurements
  • For participants who can become pregnant, use of two forms of contraception between visits 1-4, one of which must be a barrier method
Not Eligible

You will not qualify if you...

  • Limb threatening infections or extensive cellulitis beyond wound borders
  • Wound outside the size, duration, severity, or location criteria or clinically severe wounds at high risk for amputation
  • Pressure ulcers except those below the knee
  • Active cellulitis or acute infection with fever or significant wound inflammation
  • Positive wound culture for Pseudomonas after enrollment
  • Symptoms of systemic infection or uncontrolled diabetes
  • Allergy or hypersensitivity to penicillin, cefazolin, beta-lactams, cephalosporins, lidocaine, or similar local anesthetics
  • Need for intravenous antimicrobial treatment during the study
  • Currently on dialysis or awaiting dialysis or have severe kidney impairment
  • Expected inability to care for wound due to hospitalization, vacation, or disability
  • Active alcohol or substance abuse within 6 months
  • Receiving systemic corticosteroids, biologic therapy, immunosuppressants, radiation, or cytotoxic agents without authorization
  • Need for treatment of cancer other than certain skin cancers
  • AIDS or HIV positive
  • Other conditions that may affect safety or study objectives as determined by investigators
  • Women who are breastfeeding, pregnant, or trying to become pregnant
  • Medically unstable conditions including severe diabetes, unstable cardiovascular disease, severe organ disorders, recent trauma with major damage, or sickle cell disease
  • Participation in another study or refusal to refrain from other studies during this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 1 week

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day for the tumescent antibiotic injection. Standard wound care continues until the wound closes.

Participants receive a one-time tumescent antibiotic injection in addition to standard wound care, or standard wound care alone.

1 treatment visit for the injection; standard care visits as usual

Follow-up

Duration - Up to approximately 1 year

Participants are monitored with scheduled follow-up visits to assess wound healing, pain, quality of life, and safety.

Once weekly visits for 2 weeks, then biweekly visits for 4 weeks, plus visits at 3 months and 6 months

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

M

Marco Morcos

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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Published Research Related To This Trial

The Role of Macrophages in Acute and Chronic Wound Healing and Interventions to Promote Pro-wound Healing Phenotypes.

Paulina Krzyszczyk, Rene Schloss, Andre Palmer...

https://pubmed.ncbi.nlm.nih.gov/29765329

An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds.

Samuel R Nussbaum, Marissa J Carter, Caroline E Fife...

https://pubmed.ncbi.nlm.nih.gov/29304937

Tumescent Injections in Subcutaneous Pig Tissue Disperse Fluids Volumetrically and Maintain Elevated Local Concentrations of Additives for Several Hours, Suggesting a Treatment for Drug Resistant Wounds.

John P Koulakis, Joshua Rouch, Nhan Huynh...

https://pubmed.ncbi.nlm.nih.gov/32043171

Cefazolin potency against methicillin-resistant Staphylococcus aureus: a microbiologic assessment in support of a novel drug delivery system for skin and skin structure infections.

David P Nicolau, Barry N Silberg

https://pubmed.ncbi.nlm.nih.gov/28794647