Comparing two imaging methods for severe frostbite
Prospective Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite
HealthPartners Institute · NCT05777590
This study is testing which imaging method works better for diagnosing severe frostbite in adults who are receiving treatment for their injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HealthPartners Institute (other) |
| Locations | 1 site (Saint Paul, Minnesota) |
| Trial ID | NCT05777590 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of Indocyanine Green (ICG) microangiography against conventional angiography in diagnosing severe frostbite injuries in adult patients. Severe frostbite, defined as 4th degree frostbite leading to vascular occlusion and tissue ischemia, poses significant morbidity risks, particularly in colder climates like Minnesota. The study will involve adult patients diagnosed with severe frostbite who are undergoing thrombolysis treatment. By evaluating both imaging techniques, the study seeks to identify which method provides better diagnostic clarity and treatment guidance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with severe frostbite and undergoing thrombolysis.
Not a fit: Patients who are pregnant or have an iodine allergy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic practices and treatment outcomes for patients suffering from severe frostbite.
How similar studies have performed: While there have been various studies on frostbite and imaging techniques, this specific comparison of ICG microangiography and conventional angiography is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint Paul, Minnesota
- Regions Hospital — Saint Paul, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Alexandra Lacey, MD — Regions Hospital
- Study coordinator: Nicholas Larson
- Email: Nicholas.J.Larson@healthpartners.com
- Phone: 651-254-4846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Frostbite, Angiogram, Indocyanine Green, ICG