Can an enzyme gel dissolve burned tissue without surgery?
NCT ID NCT06628037
First seen Aug 07, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This trial tests a gel made from the enzyme SN514 to see if it can safely and effectively remove dead tissue from deep partial-thickness burns. Adults with suitable burns will receive daily applications of the gel for up to seven days, with different concentrations tested in small groups. The goal is to find the highest dose that is well-tolerated and to measure how much dead tissue is removed over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SN514-066b, an enzyme gel applied to burn wounds to remove dead tissue
- What this could lead to
- If successful, this could provide a less painful, non-surgical way to clean deep burn wounds, potentially improving healing and reducing scarring.
- What could go wrong
- This is an early-phase dose-finding study with a small number of participants. The enzyme may not work as hoped, or it could cause significant side effects like pain or irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: 1. Thermal burns caused by fire/flame, scalds or contact 2. Total burns area available for treatment is 25 to 500 cm2 (a larger area may be burned, but the treatment area must be limited to the stated size, and the treatment area must be exclusive of face, hands, genitalia and sites deemed to be at high risk for developing compartment syndrome) 3. Target burns for treatment is deep partial thickness (DPT) in depth Main Exclusion Criteria: 1. Subject has another life threatening traumatic injury 2. Patient's proposed study wound site has any of the following conditions: * Electrical or chemical etiology * Pre-enrollment escharotomy * Area is devoid of circulation * Located on the face, perineum or genitalia * Clinical evidence of wound infection 3. Poorly controlled diabetes mellitus (HbA1c \>12%) 4. BMI greater than 40 kg/m2 5. Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable ischemic heart disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma, or uncontrolled asthma) 6. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins) 7. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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USAISR Burn Center
San Antonio, Texas, 78234, United States
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