BridgeMD
New treatment option for Non-healing Wound
Official title Antibiotic Tumescent For Chronic Wounds
ClinicalTrials.gov ID: NCT06327113
What this study is testing
What is CeFAZolin Injectable Solution?
CeFAZolin Injectable Solution is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for non-healing wound.
Also referred to as Kefzol, Ancef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Presence of a chronic wound (including venous ulcer, arterial ulcer, below knee pressure ulcer, diabetic foot ulcer, ischemic ulcer) that has existed...
- Documentation that the wound has been treated at least 2 times at the wound care center.
You likely can't join if
- Participants with limb threatening infection, extensive cellulitis (≥2 cm radially beyond the borders of the wound), lymphangitis, fasciitis, deep...
- Wound size/surface area, duration, severity, or location outside of INCLUSION criteria Note: Consideration will be given to minor variation, if...
- 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...
See the full eligibility criteria
- 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...
- 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 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
- 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.