New dye test could replace risky X-Rays for frostbite diagnosis
NCT ID NCT05777590
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 4 times
Summary
This pilot study compares two imaging methods—ICG microangiography and conventional angiography—in 8 adults with severe frostbite. The goal is to see if the safer ICG dye test can accurately show damaged tissue, potentially replacing the standard angiogram that uses contrast dye with kidney risks. If they match, doctors may have a simpler, safer way to assess frostbite severity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Indocyanine Green (ICG) dye
- What this could lead to
- If successful, this could show that ICG microangiography is a reliable alternative to conventional angiography for diagnosing severe frostbite, potentially simplifying diagnosis and reducing risks from contrast dye.
- What could go wrong
- This is a very small pilot study with only 8 participants, so results may not apply broadly. The study is not testing a treatment, only comparing imaging methods, so it won't directly improve frostbite outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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8 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients undergoing conventional angiography and thrombolysis for severe frostbite. will be identified by the burn surgeons and advance practice practitioners. They will evaluate the patients to determine whether they meet the inclusion/exclusion criteria of the study.
- Ages
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18 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult (\>18 years old) patients 2. Diagnosed with severe frostbite by conventional angiography 3. Undergoing thrombolysis with catheter directed lytics 4. Clinically sober at the time of consent 5. Cognitively able to provide consent as determined by clinician's best judgement 6. Normal kidney function (GFR \>60) Exclusion Criteria: 1. Pregnant. Pregnancy will be determined by standard of care pregnancy test performed on all female frostbite patients who are receiving lytics. 2. Iodine allergy.
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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.
Contacts and locations
Locations
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Regions Hospital
Saint Paul, Minnesota, 55101, United States
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