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NCT07424378 · ClinicalTrials.gov registry record · Phase 4
Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO)
A Phase 4 study, sponsored by University of Colorado, Denver.
- Not yet
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT07424378: Clinical Trial Phase 4 study, sponsored by University of Colorado, Denver.
NCT07424378 is a Phase 4 study that has not yet begun recruiting, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07424378, a Phase 4 study, has not yet begun recruiting, sponsored by University of Colorado, Denver.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
Severe frostbite injury can result in significant lifelong disability and amputation. Various medicines, including intravenous vasodilators (prostaglandins/iloprost, pentoxifylline, buflomedil) along with thrombolytics (alteplase), have been described to counter tissue ischemia after rewarming, with poor quality of evidence. An in-class prostacyclin, epoprostenol, has similar pharmacodynamic properties to iloprost including vasodilation and platelet inhibition and has been used in peripheral tissue ischemia such as Raynaud's and scleroderma. In this trial, we will evaluate the effectiveness and safety of epoprostenol treatment for severe frostbite injury in addition to standard of care.
Primary Outcome
Amputation rate within 90 days of frostbite injury, defined as number of amputations per number of digits affected.
Interventions
- DRUG Standard of care plus Epoprostenol infusion for 8 hours (hrs) per day up to 5 days maximum
- DRUG Standard of Care + Placebo (Normal Saline)infusion for 8 hours per day up to 5 days maximum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-02 |
| Est. Completion | 2028-11 |
| Phase | Phase 4 |
What is known before NCT07424378 opens enrollment
NCT07424378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care plus Epoprostenol infusion for 8 hours (hrs) per day up to 5 days maximum is the first listed.
NCT07424378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07424378 about?
NCT07424378 is a clinical study titled "Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO)". Severe frostbite injury can result in significant lifelong disability and amputation. Various medicines, including intravenous vasodilators (prostaglandins/iloprost, pentoxifylline, buflomedil) along with thrombolytics (alteplase), have been described to counter tissue ischemia after rewarming, with...
What is the current status of trial NCT07424378?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2026-02. Estimated completion is 2028-11.
What interventions are being tested in trial NCT07424378?
The interventions under investigation include: Standard of care plus Epoprostenol infusion for 8 hours (hrs) per day up to 5 days maximum (DRUG), Standard of Care + Placebo (Normal Saline)infusion for 8 hours per day up to 5 days maximum (DRUG).
Who is sponsoring clinical trial NCT07424378?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07424378's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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