Frostbite breakthrough? new drug trial aims to save limbs
NCT ID NCT07424378
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug epoprostenol, given alongside standard care, can reduce the need for amputation in people with severe frostbite. About 66 adults with grade 2-4 frostbite will receive either the drug or a placebo within 72 hours after rewarming. The goal is to see if the drug helps save fingers and toes by improving blood flow.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Feb 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
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.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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.
Inclusion Criteria: 1. Aged ≥ 18 years 2. Admitted to University of Colorado Hospital (UCH) Burn and Frostbite Center 3. Cauchy Grade 2-4 frostbite injury 4. Admission within 72 hours post-rewarming Exclusion Criteria: 1. Patients unable to initiate therapy within 72 hours post-rewarming 2. Unsalvageable frostbite as defined by obvious necrosis of tissue, wet gangrene, or other condition requiring amputation (within the first week) 3. Anticipated death within 48 hours of admission 4. Pregnant or breastfeeding patients 5. Prisoners 6. Inability to obtain consent from patient or legally authorized representative (LAR) or proxy 7. Not a good candidate for treatment per treating physician or investigator 8. Patients with known allergy/hypersensitivity to epoprostenol 9. Current or planned receipt of other prostaglandin analog (iloprost and treprostinil) 10. Known congestive heart failure due to severe left ventricular systolic dysfunction (New York Heart Association (NYHA) class III/IV) 11. Known right heart failure (RHF) 12. Hypotension unresponsive to fluids and discontinuation of concomitant anti-hypertensives (mean arterial pressure (MAP) \< 65 mmHg) 13. Known pulmonary hypertension
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Frostbite are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
University of Colorado, Denver
Aurora, Colorado, 80045, United States
-
University of Colorado, Denver
Aurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.