Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite
Completed
Conditions studied: Frostbite
In brief
Severe frostbite injury is a significant cause of morbidity in northern climates. Minnesota has some of the highest numbers of severe frostbite injuries in North America. As a result, Regions Hospital has the best opportunity to study this disease process and improve outcomes for frostbite patients. The diagnostic methods for severe frostbite injury vary from institution to institution and there is no standard practice. Commonly utilized methods include conventional angiography, Technetium 99 triple phase bone scans, SPECT studies, Indocyanine Green microangiography, and doppler studies. The proposed pilot study aims to directly compare conventional angiography imaging to ICG microangiography in adult patients with severe frostbite. Severe frostbite is defined as 4th degree: frostbite resulting in vascular occlusion and tissue ischemia. Both imaging modalities have been used for the diagnosis and monitoring of severe frostbite injury but there has never been a study directly comparing these two imaging modalities.
Key facts
- Study ID
- NCT05777590
- Run by
- HealthPartners Institute
- People needed
- 8
- Starts
- 2023-02-03
- Expected to finish
- 2026-06-03
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult (>18 years old) patients
- Diagnosed with severe frostbite by conventional angiography
- Undergoing thrombolysis with catheter directed lytics
- Clinically sober at the time of consent
- Cognitively able to provide consent as determined by clinician's best judgement
- Normal kidney function (GFR >60)
You may not qualify if…
- Pregnant. Pregnancy will be determined by standard of care pregnancy test performed on all female frostbite patients who are receiving lytics.
- Iodine allergy.
Where it is running
- Regions Hospital — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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