Antibiotic Tumescent For Chronic Wounds

NCT06327113 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB#23-001248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-healing Wound

Keywords

chronic wound; wound care

Outcome Measures

Primary Outcomes (1)

• Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI

  Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, and the relationship to TAI. The severity of adverse events will be measured by the adverse event severity scale (1-4; Mild; Moderate; Severe; Life-threatening). The relationship of the adverse event to the study drug will be assessed by the likelihood of the relationship (Definitely; Probably; Possibly; Unrelated). Frequency of adverse events that result in discontinuation of the investigative treatment will be quantified.

  From enrollment through 6 month visit.

Secondary Outcomes (3)

• Secondary Objective - To evaluate wound size and closure.

  From enrollment through 6 month visit or until wound is closed.

• Secondary Objective - Chronic-wound-related pain

  From enrollment through 6 month visit.

• Secondary Objective - Rating Quality of life

  From enrollment through 6 month visit.

Other Outcomes (3)

• Exploratory Objectives - Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis).

  From enrollment through 6 month visit.

• Exploratory Objectives - Assess the number of clinical signs of infection in participants.

  From enrollment through 6 month visit.

• Exploratory Objectives - Determine the species of pathogenic bacteria present in wound.

  From enrollment through 6 month visit.

Study Arms (2)

Control Group (Standard Wound Care)

NO INTERVENTION

The 'control' group will receive wound care treatment in accordance to standard of care procedures. The 'control' group will not receive study intervention.

Treatment Group (Tumescent Antibiotic Injection)

EXPERIMENTAL

The 'treatment' group will receive wound care treatment in accordance to standard of care procedures along with the study intervention, a one-time tumescent antibiotic injection (TAI).

Drug: CeFAZolin Injectable Solution

Interventions

CeFAZolin Injectable Solution DRUG

One gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)

Also known as: Kefzol, Ancef

Treatment Group (Tumescent Antibiotic Injection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age.
• Must have:
• 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).
• 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.
• Documentation that the wound has been treated at least 2 times at the wound care center.
• Documentation that the wound area has not decreased by more than 50% in 4 weeks.
• 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:
• Condoms (male or female) with or without a spermicidal agent
• Diaphragm or cervical cap with spermicide
• Intrauterine device (IUD)
• Tubal ligation
• Hormone-based contraceptive such as oral birth control pills

You may not qualify if:

• 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.
• Clinically severe wound at high risk for amputation as determined by the Medical Director.
• All pressure ulcers except below knee pressure ulcers.
• Cellulitis or acute infection as determined by:
• Significant wound erythema, induration, warmth, presence of pus, or tenderness, determined by PI or medical director ≥ 2 cm radially from wound margin.
• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (15)

• Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

  PMID: 28614678 BACKGROUND

• O'Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000265. doi: 10.1002/14651858.CD000265.pub3.

  PMID: 23152202 BACKGROUND

• Krzyszczyk P, Schloss R, Palmer A, Berthiaume F. The Role of Macrophages in Acute and Chronic Wound Healing and Interventions to Promote Pro-wound Healing Phenotypes. Front Physiol. 2018 May 1;9:419. doi: 10.3389/fphys.2018.00419. eCollection 2018.

  PMID: 29765329 BACKGROUND

• Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

  PMID: 19903300 BACKGROUND

• Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. Epub 2017 Sep 19.

  PMID: 29304937 BACKGROUND

• Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847.

  PMID: 24130936 BACKGROUND

• Koulakis JP, Rouch J, Huynh N, Wu HH, Dunn JCY, Putterman S. 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. Pharm Res. 2020 Feb 10;37(3):51. doi: 10.1007/s11095-020-2769-2.

  PMID: 32043171 BACKGROUND

• Nicolau DP, Silberg BN. Cefazolin potency against methicillin-resistant Staphylococcus aureus: a microbiologic assessment in support of a novel drug delivery system for skin and skin structure infections. Infect Drug Resist. 2017 Jul 26;10:227-230. doi: 10.2147/IDR.S134497. eCollection 2017.

  PMID: 28794647 BACKGROUND

• Okuma K, Iwakawa K, Turnidge JD, Grubb WB, Bell JM, O'Brien FG, Coombs GW, Pearman JW, Tenover FC, Kapi M, Tiensasitorn C, Ito T, Hiramatsu K. Dissemination of new methicillin-resistant Staphylococcus aureus clones in the community. J Clin Microbiol. 2002 Nov;40(11):4289-94. doi: 10.1128/JCM.40.11.4289-4294.2002.

  PMID: 12409412 BACKGROUND

• Durand BARN, Pouget C, Magnan C, Molle V, Lavigne JP, Dunyach-Remy C. Bacterial Interactions in the Context of Chronic Wound Biofilm: A Review. Microorganisms. 2022 Jul 25;10(8):1500. doi: 10.3390/microorganisms10081500.

  PMID: 35893558 BACKGROUND

• Kim H, Park H, Lee SJ. Effective method for drug injection into subcutaneous tissue. Sci Rep. 2017 Aug 29;7(1):9613. doi: 10.1038/s41598-017-10110-w.

  PMID: 28852051 BACKGROUND

• Scali C, Kunimoto B. An update on chronic wounds and the role of biofilms. J Cutan Med Surg. 2013 Nov-Dec;17(6):371-6. doi: 10.2310/7750.2013.12129.

  PMID: 24138971 BACKGROUND

• Boeni R. Safety of tumescent liposuction under local anesthesia in a series of 4,380 patients. Dermatology. 2011;222(3):278-81. doi: 10.1159/000327375. Epub 2011 May 24.

  PMID: 21606638 BACKGROUND

• Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.

  PMID: 19947907 BACKGROUND

• Coerper S, Beckert S, Kuper MA, Jekov M, Konigsrainer A. Fifty percent area reduction after 4 weeks of treatment is a reliable indicator for healing--analysis of a single-center cohort of 704 diabetic patients. J Diabetes Complications. 2009 Jan-Feb;23(1):49-53. doi: 10.1016/j.jdiacomp.2008.02.001. Epub 2008 Apr 3.

  PMID: 18394932 BACKGROUND

Related Links

• UCLA Center for Wound Healing \& Limb Preservation

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seth Putterman, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

Andrew Vardanian, MD

CONTACT

310-825-8927; avardanian@mednet.ucla.edu

Marco Morcos

CONTACT

310-825-9225; mmorcos@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physics and Astronomy at University of California, Los Angeles

Model Details: This is a single center, prospective, comparative interventional, two-arm parallel group, randomized, clinical safety and efficacy trial comparing a group receiving standard wound care with tumescent antibiotic injection (TAI) with a control group receiving standard wound care

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 25, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)