RECRUITING

Antibiotic Tumescent For Chronic Wounds

Conditions

Non-healing Wound chronic wound wound care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-17

Study Completion:2028-05-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06327113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Andrew Vardanian, MD

CONTACT

310-825-8927

avardanian@mednet.ucla.edu

Marco Morcos

CONTACT

310-825-9225

mmorcos@mednet.ucla.edu

Principal Investigator

Seth Putterman, PhD

STUDY_DIRECTOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Seth Putterman, PhD, STUDY_DIRECTOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-17

Study Completion Date2028-05-25

Study Record Updates

Study Start Date2024-05-17

Study Completion Date2028-05-25

Terms related to this study

Keywords Provided by Researchers

chronic wound
wound care

Additional Relevant MeSH Terms

Non-healing Wound