Clinical trial • Phase IV • Dermatology
ILOPROST for Frostbite injury to extremities
Phase IV trial of ILOPROST for Frostbite injury to extremities.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Frostbite injury to extremities
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 29-01-2025
- First CTIS Authorization Date
- 30-01-2025
Trial design
Randomised, iloprost (iloprost) — intravenous infusion; max daily dose 720 ng, max total dose 2160 ng, treatment period up to 3 days. comparator: alteplase (alteplase) — intra-arterial use; max daily dose 26.5 mg, max total dose 53 mg, treatment period up to 2 days.-controlled Phase IV trial in Finland.
- Randomised
- Yes
- Comparator
- Iloprost (ILOPROST) — Intravenous infusion; max daily dose 720 ng, max total dose 2160 ng, treatment period up to 3 days. Comparator: Alteplase (ALTEPLASE) — Intra-arterial use; max daily dose 26.5 mg, max total dose 53 mg, treatment period up to 2 days.
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable population selected. Informed consent documents provided (subject information and informed consent form) in Finnish..
- Vulnerable Population
- No vulnerable population selected. Informed consent documents provided (subject information and informed consent form) in Finnish.
Inclusion criteria
- {"criterion_text":"- Severe distal extremity frostbite"}
Exclusion criteria
- {"criterion_text":"- Contraindications to either tPA or iloprost therapy, less than 18 years age, non-severe frostbite"}
Endpoints
Primary endpoints
- {"endpoint_text":"- level of distal extremity / digital amputation","definition_or_measurement_approach":"Review rates and levels of distal extremity amputations and record clinical outcome; aim to accrue at least 50 patients to review rates and levels of distal extremity amputations and long-term functional outcome."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 144
- Consent Approach
- Informed consent obtained from adult participants; consent documents (subject information and informed consent form) provided in Finnish. Participants under 18 years are excluded, so no assent procedures specified.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 100
Finland
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 1
- Number Of Sites
- 5
- Number Of Participants
- 100
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Outi Kaarela
- Contact Person Email
- outi.kaarela@oulu.fi
- Site Name
- Tampere University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Juha Kiiski
- Contact Person Email
- juha.kiiski@pirha.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Helsinki Burn Centre
- Contact Person Name
- Andrew Lindford
- Contact Person Email
- andrew.lindford@hus.fi
- Site Name
- Turku University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Tarja Niemi
- Contact Person Email
- tarja.niemi@tyks.fi
- Site Name
- Kuopio University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Helli Väänänen
- Contact Person Email
- helli.vaananen@kuh.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- ILOPROST
- Active Substance
- ILOPROST
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- Max daily dose 720 ng; max total dose 2160 ng
- Investigational Product Name
- ALTEPLASE
- Active Substance
- ALTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intra-arterial use
- Route
- Intra-arterial
- Maximum Dose
- Max daily dose 26.5 mg; max total dose 53 mg
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