Injecting antibiotics to treat chronic wounds

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

This study tests if injecting antibiotics can help people with chronic wounds heal better than just standard wound care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06327113 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of tumescent antibiotic injections for patients with chronic non-healing wounds. Eligible participants will be randomized to receive either standard wound care or the antibiotic treatment, with both groups continuing standard care protocols. The study will involve approximately six visits over six months, during which wound size and healing progress will be monitored, and patient surveys will be conducted. The goal is to evaluate whether this novel approach can improve healing outcomes for chronic wounds.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic full-thickness ulcers on the lower or upper extremities or trunk that have not improved after standard treatment.

Not a fit: Patients with wounds that are not full-thickness or those who have not received prior treatment at a wound care center may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance healing rates for patients with chronic wounds, potentially reducing healthcare costs and improving quality of life.

How similar studies have performed: While this specific approach is novel, previous studies have shown promise in using localized antibiotic delivery methods for wound care.

Eligibility criteria

Inclusion Criteria:

* Male or female ≥18 years of age.
* Must have:

  1. One or more full thickness ulcers on the lower extremity, upper extremity (excluding the hands) or trunk with a surface area exceeding 0.5 cm\^2 (50 mm\^2) and less than 30 cm\^2 (6\*5 cm) after debridement (full thickness means extending through the epidermis and dermis but not involving tendon, bone or joint capsule).
  2. Presence of a chronic wound (including venous ulcer, arterial ulcer, below knee pressure ulcer, diabetic foot ulcer, ischemic ulcer) that has existed for \>4 weeks at Visit 1.
  3. Documentation that the wound has been treated at least 2 times at the wound care center.
  4. Documentation that the wound area has not decreased by more than 50% in 4 weeks.
  5. Willing to provide written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
* Adequate perfusion as demonstrated by TcPO2≥40 mm Hg, ABI ≥ 0.7, or great toe pressure≥50 mm Hg, or palpable pulses of the lower extremity such as dorsalis pedis and/or posterior tibial artery or palpable radial artery in the upper extremity.
* In the opinion of the investigator, participants must be considered reliable, willing, and able to give signed informed consent in English and sign the informed consent form.
* For participants of reproductive potential, two of the following forms of contraception are required between visits 1-4 (total of 3-6 weeks), one of which must be a barrier method:

  1. Condoms (male or female) with or without a spermicidal agent
  2. Diaphragm or cervical cap with spermicide
  3. Intrauterine device (IUD)
  4. Tubal ligation
  5. Hormone-based contraceptive such as oral birth control pills

Exclusion Criteria:

* Participants with limb threatening infection, extensive cellulitis (≥2 cm radially beyond the borders of the wound), lymphangitis, fasciitis, deep tissue infection, abscess, pus, osteomyelitis, or other evidence of local or systemic complications of infection.

  1. Wound size/surface area, duration, severity, or location outside of INCLUSION criteria Note: Consideration will be given to minor variation, if deemed appropriate by the medical director, and authorized.
  2. Clinically severe wound at high risk for amputation as determined by the Medical Director.
  3. All pressure ulcers except below knee pressure ulcers.
* Cellulitis or acute infection as determined by:

  1. Significant wound erythema, induration, warmth, presence of pus, or tenderness, determined by PI or medical director ≥ 2 cm radially from wound margin.
  2. Fever with electronic temp \>100.4°F (\>38°C)
* Following enrollment, if wound culture returns positive for Pseudomonas.
* Participants with symptoms of systemic infection or uncontrolled diabetes mellitus (e.g., severe hyperglycemia, ketoacidosis, azotemia).
* Participants who are allergic or have shown hypersensitivity to penicillin, cefazolin, other beta-lactams, the cephalosporin group of antibiotics, lidocaine, or to local anesthetics of the amide type.
* Participants requiring intravenous antimicrobials during the study period for any infection, including diabetic foot ulcer. Mild localized infection that would be treated on an outpatient basis could be approved by Medical Director authorization.
* Participants who are currently treated by dialysis, awaiting dialysis, or who have an estimated glomerular filtration rate of ≤ 30 mL/min/1.73 m\^2.
* Participants who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc., during the study period.
* Participants with known active alcohol or substance abuse within the 6 months preceding study entry.
* Participants who are receiving systemic corticosteroids (in a dose equivalent to ≥20 mg of prednisone per day), biologic therapy, immunosuppressants, , radiation therapy, or cytotoxic agents, unless approved by medical director authorization
* Participants who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin, not involving the wound site).
* Participants with acquired immune deficiency syndrome (AIDS) or known human immunodeficiency virus (HIV) positivity.
* Participants with other conditions considered by the investigator to be reasons for disqualification that may jeopardize participant safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
* Women who are breastfeeding, pregnant, or attempting to become pregnant.
* Active acute medically unstable condition defined by:

  1. Diabetes Mellitus Type 1 or 2, with A1C greater than 9.5. Consideration to HbA1c higher than 9.5 - 10.0% after consultation with the medical director or PI.
  2. Unstable cardiovascular or other high-risk general medical condition making participation in the study a significant risk to the participant, per medical director determination.
  3. Laboratory evidence of severe metabolic, renal, hepatic, endocrine, hematologic disorder per medical director determination.
  4. Recent trauma complicated by significant bone, nerve, or vascular damage.
  5. Sickle Cell Disease.
* Participant is enrolled/participating in another study or does not agree to refrain from participating in another study while enrolled in this study.

Where this trial is running

Los Angeles, California

• University of California, Los Angeles — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Andrew Vardanian, MD

Conditions Non-healing Wound; chronic wound; wound care