Non-healing WoundPhase 2TAINCT06327113
Antibiotic Tumescent For Chronic Wounds
A Phase 2 study testing CeFAZolin Injectable Solution in people with Non-healing Wound, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-healing Wound
- What is being tested?
- CeFAZolin Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 25 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
- 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.
- 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.
Show all 26Show fewer
- 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:
- 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.
- Unstable cardiovascular or other high-risk general medical condition making participation in the study a significant risk to the participant, per medical director determination.
- Laboratory evidence of severe metabolic, renal, hepatic, endocrine, hematologic disorder per medical director determination.
- Recent trauma complicated by significant bone, nerve, or vascular damage.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Steven Stokes, 310-206-7436, sstokes@mednet.ucla.edu
Jenny Lester, MPH, 310-794-9728, jlester@mednet.ucla.edu
About this study
Official title: A Phase 2 Randomized Study Comparing Subcutaneous Tumescent Antibiotic Administration With Standard of Care for the Treatment of Chronic Wounds
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.
Read the 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
- To assess the safety of tumescent antibiotic injections.
Secondary Objectives
- To evaluate wound size or closure.
- To evaluate chronic-wound-related pain.
- To evaluate Quality of Life.
Exploratory Objectives
- Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis).
- Assess the number of clinical signs of infection in participants.
- 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
- Being tested
- CeFAZolin Injectable Solution
- Keywords
- chronic wound, wound care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeFAZolin Injectable SolutionDrug
Also called Kefzol, Ancef
One gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: CeFAZolin Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through 6 month visit.
Secondary outcomes (3)
Secondary Objective - To evaluate wound size and closure.
Wound closure will be determined by the clinical practitioner at time of wound assessment at clinic follow up. If wound is not closed, wound size will be measured with a device that scans the wound and determines its area in cm^2. If wound is closed the wound size will be returned as 0 cm^2.
Measured: From enrollment through 6 month visit or until wound is closed.
Secondary Objective - Chronic-wound-related pain
Chronic wound-related pain will me be measured with a pain assessment administered every visit. The pain assessment is the PEG-3 Pain Screening Tool which consists of 3 questions; The PEG-3 answer scale ranges from 0 to 10 for each question, where 0 corresponds to no pain and 10 represents the worst pain. A combined score is generated by summing the answer to each question.
Measured: From enrollment through 6 month visit.
Secondary Objective - Rating Quality of life
Quality of Life (QoL) will be measured with a QoL assessment administered at every visit.
The QoL assessment is the WOUND-QOL-14 QUESTIONNAIRE which consists of 14 questions. Answers to each item are coded with numbers (0='not at all', 1='a little', 2='moderately', 3='quite a lot', to 4='very much') and summed or averaged to generate a global score. A higher score denotes a lower QoL.
Measured: From enrollment through 6 month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start17 May 2024
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth J Putterman, University of California, Los Angeles
- Investigators
- Seth Putterman, PhD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327113
- Sponsor's protocol ID
- IRB#23-001248
- Acronym
- TAI
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 28614678O'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.
PubMed 23152202Krzyszczyk 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.
PubMed 29765329Sen 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.
PubMed 19903300Nussbaum 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.
PubMed 29304937Barshes 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.
PubMed 24130936Koulakis 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.
PubMed 32043171Nicolau 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.
PubMed 28794647Okuma 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.
PubMed 12409412Durand 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.
PubMed 35893558Kim 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.
PubMed 28852051Scali 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.
PubMed 24138971Boeni 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.
PubMed 21606638Harb 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.
PubMed 19947907Coerper 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.
PubMed 18394932
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study Comparing Subcutaneous Tumescent Antibiotic Administration With Standard of Care for the Treatment of Chronic Wounds
- ClinicalTrials.gov ID
- NCT06327113
- Acronym / sponsor ID
- TAI / IRB#23-001248
- Conditions
- Non-healing Wound
- Keywords
- chronic wound, wound care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To assess the safety of tumescent antibiotic injections.
Secondary Objectives
- To evaluate wound size or closure.
- To evaluate chronic-wound-related pain.
- To evaluate Quality of Life.
Exploratory Objectives
- Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis).
- Assess the number of clinical signs of infection in participants.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: CeFAZolin Injectable SolutionThe '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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female ≥18 years of age.
- Must have:
- 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:
Key exclusion criteria (26 listed)
- 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.
- Cellulitis or acute infection as determined by:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeFAZolin Injectable SolutionAlso: Kefzol, AncefOne gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline) | Drug | Treatment Group (Tumescent Antibiotic Injection) |
Primary outcome
Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI
Time frame: From enrollment through 6 month visit.
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.
3 secondary outcomes
Secondary Objective - To evaluate wound size and closure.
Time frame: From enrollment through 6 month visit or until wound is closed.
Secondary Objective - Chronic-wound-related pain
Time frame: From enrollment through 6 month visit.
Secondary Objective - Rating Quality of life
Time frame: From enrollment through 6 month visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 28614678Armstrong 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.
- Background: PubMed 23152202O'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.
- Background: PubMed 29765329Krzyszczyk 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.
- Background: PubMed 19903300Sen 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.
- Background: PubMed 29304937Nussbaum 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.
- Background: PubMed 24130936Barshes 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.
- Background: PubMed 32043171Koulakis 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.
- Background: PubMed 28794647Nicolau 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.
- Background: PubMed 12409412Okuma 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.
- Background: PubMed 35893558Durand 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.
- Background: PubMed 28852051Kim 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.
- Background: PubMed 24138971Scali 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.
- UCLA Center for Wound Healing \& Limb PreservationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seth Putterman, PhD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CeFAZolin Injectable Solution in people with Non-healing Wound, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Vardanian, MD (310-825-8927, avardanian@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI (time frame: From enrollment through 6 month visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327113, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.