Overview
Sponsor-declared trial summary
Frostbite injury to extremities
To randomize into 2 groups all severe cases of frostbite to be treated with iloprost or tPA as non-inferiority trial. Prospective data will be collected and clinical outcome recorded. The aim is to accrue at least 50 patients and review rates and levels of distal extremity amputations as well as long-term functional ou…
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520291-10-01
- EudraCT number
- 2018-000712-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To randomize into 2 groups all severe cases of frostbite to be treated with iloprost or tPA as non-inferiority trial. Prospective data will be collected and clinical outcome recorded. The aim is to accrue at least 50 patients and review rates and levels of distal extremity amputations as well as long-term functional outcome. Furthermore various haematological variables will be recorded prior to and after treatment.
Conditions and MedDRA coding
Frostbite injury to extremities
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-520291-10-00 | Prospective Randomised Nordic Frostbite Treatment Study comparing tPA and iloprost therapy | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Severe distal extremity frostbite
Exclusion criteria 1
- Contraindications to either tPA or iloprost therapy, less than 18 years age, non-severe frostbite
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- level of distal extremity / digital amputation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP108772364 · ATC
- Active substance
- Iloprost
- Substance synonyms
- (5E)-(3AS,4R,5R,6AS)-5-HYDROXY-4-((1E)-(3S,4RS)-3-HYDROXY-4-METHYLOCT-1-EN-6-YNYL)-HEXAHYDROPENTALEN-2(1H)-YLIDENE)PENTANOIC ACID, ZK-36374
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 720 ng nanogram(s)
- Max total dose
- 2160 ng nanogram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC11 — ILOPROST
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SCP19334083 · ATC
- Active substance
- Alteplase
- Substance synonyms
- RT-PA
- Route of administration
- INTRAARTERIAL USE
- Max daily dose
- 26.5 mg milligram(s)
- Max total dose
- 53 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AD02 — ALTEPLASE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Andrew Lindford
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Andrew Lindford
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 100 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Frostbite Research Plan | 1 |
| Protocol (for publication) | Frostbite research protocol Fimea 2025 | 1 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Subject information and informed consent form (for publication) | Paleltumavammatutkimus suostumuslomake suomeksi FINAL | 1 |
| Subject information and informed consent form (for publication) | Potilastiedote paleltumavamma suomeksi-FINAL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ACTILYSE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ILOMEDIN | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Finland | Acceptable 2025-01-29
|
2025-01-30 |