NCT06327113

Antibiotic Tumescent For Chronic Wounds

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Foot ulcers develop in 9.1-26 million people with diabetes annually worldwide. Up to 1% of people in industrialized countries will suffer from a leg ulcer. Numbers of pressure and venous ulcers are rising at rates of 6-7% annually, diabetic ulcers rising at 9%. In the United States, chronic wounds affect 6.5 million patients and over $25 billion dollars are spent annually on chronic wound care. Medicare spending on pressure and arterial ulcers in 2014 was $3696 and $9015 per patient. Diabetic limb complications are more costly than breast cancer. Attempts to treat chronic wounds have included 1) debridement, 2) specialized dressings, 3) compression bandages, 4) negative pressure devices, 5) topical growth factors and pharmaceuticals, 6) skin grafts and skin substitutes, 7) hyperbaric oxygen therapy and 8) amputation. There is no study that examines the utility of tumescent antibiotic injections (TAI) into a wound. TAI is a relatively simple, cost-effective procedure using known, drugs with a well characterized safety profile, and used in a new way to address this large unmet need. Our group has published work in this area showing appropriate design, feasibility and safety in a large animal model. The investigators have shown that direct antibiotic delivery through tumescent injections can achieve high antibiotic concentrations directly in skin and soft tissue for sufficient time to kill bacteria. Simultaneously, total antibiotic doses can be kept low, minimizing systemic toxicity. In particular, even antibiotic resistant strains of pathogenic microorganisms may be susceptible due to the high local concentration of antimicrobial agent. Tumescent injections can more effectively deliver antibiotic to compromised body regions with impaired circulation compared to intramuscular or intravenous drug delivery. Primary Objective 1\. To assess the safety of tumescent antibiotic injections. Secondary Objectives 1. To evaluate wound size or closure. 2. To evaluate chronic-wound-related pain. 3. To evaluate Quality of Life. Exploratory Objectives 1. Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis). 2. Assess the number of clinical signs of infection in participants. 3. Determine the species of pathogenic bacteria present in wound. Screening: up to 1 week. Treatment: TAI will take 1 day. Standard wound care will be ongoing until the wound closes, as it would in a wound care center. Follow-up: Once weekly (+/-1 week) for 2 weeks, followed by Biweekly (+/-1week) for 4 more weeks. There will also be a 3 month (+/- 2 weeks) and 6 month (+/- 4 weeks) follow up visits. Total duration of participant participation is up to approximately 1 year. Total duration of the study for recruitment and completion of visits is expected to be up to two years.

Conditions

• Non-healing Wound

Interventions

Type	Name	Description
DRUG	CeFAZolin Injectable Solution	One gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)

Timeline

• Start date: 2024-05-17
• Primary completion: 2027-05-25
• Completion: 2028-05-25
• First posted: 2024-03-25
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study