Not yet recruitingRare disease

Study on Frostbite Treatment for Severe Cases Using Alteplase and Iloprost

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on treating severe cases of frostbite, which is an injury caused by freezing of the skin and underlying tissues, typically affecting the extremities like fingers and toes. The study is comparing two treatments: iloprost and tPA (also known as alteplase). Iloprost is administered through an intravenous infusion, which means it is given directly into a vein, while tPA is used intra-arterially, meaning it is delivered directly into an artery.

The purpose of the study is to determine if iloprost is as effective as tPA in treating severe frostbite. Participants will be randomly assigned to receive either iloprost or tPA. The study will collect data on the outcomes of these treatments, including the rate and level of amputations of the affected extremities and the long-term functional outcomes. Additionally, various blood-related variables will be recorded before and after the treatment to gather more information about the effects of these medications.

The study aims to include at least 50 participants to ensure reliable results. By comparing the two treatments, researchers hope to find the best approach to reduce the need for amputations and improve recovery for those suffering from severe frostbite. The trial will continue until enough data is collected to make a clear comparison between the two treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient is enrolled based on the presence of severe frostbite in the extremities. This is the main criterion for participation.
Step 2
Randomization
The patient is randomly assigned to one of two treatment groups. One group receives alteplase and the other receives iloprost. This process ensures that the study results are unbiased.
Step 3
Treatment administration
If assigned to the alteplase group, the patient receives the medication through intraarterial use. This involves delivering the medication directly into an artery.
If assigned to the iloprost group, the patient receives the medication through intravenous infusion. This involves delivering the medication directly into a vein.
The specific dosage, frequency, and duration of administration are determined by the study protocol and are monitored by the medical team.
Step 4
Data collection
Throughout the treatment, data is collected on the patient's response to the medication. This includes monitoring the level of frostbite injury and any changes in the condition of the extremities.
Step 5
Outcome assessment
The primary outcome assessed is the level of amputation required, if any, in the affected extremities. This helps determine the effectiveness of the treatment.
Secondary outcomes include long-term functional outcomes and various blood-related variables recorded before and after treatment.
Step 6
Follow-up
The patient is monitored over time to assess the long-term effects of the treatment. This includes evaluating the functional recovery of the extremities.

Who can join the trial?

5 criteria

The patient must have a **severe frostbite** injury. Frostbite is when the skin and other tissues freeze due to very cold temperatures.
The frostbite must affect the **distal extremities**, which means the parts of the body farthest from the center, like fingers and toes.
The patient must be between the ages of **18 and 64**.
Both **men and women** can participate in the study.
The patient should not be part of a **vulnerable population**, which means they should not be in a group that needs special protection or care.

Who cannot join the trial?

3 criteria

Patients who do not have a severe case of frostbite injury to their arms or legs cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes young adults and older adults.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helsinki University Central Hospital
Verified
Helsinki, Finland
Kuopio University Hospital
Verified
Kuopio, Finland
Oulu University Hospital
Verified
Oulu, Finland

Trial locations

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Investigated drugs

tPA
is a medication used to help dissolve blood clots. In the context of this trial, it is being tested to see if it can effectively treat severe frostbite by improving blood flow to the affected areas, potentially reducing the need for amputations and improving long-term outcomes.
Iloprost
is a medication that helps to widen blood vessels and improve blood flow. It is being used in this trial to treat severe frostbite, with the goal of reducing tissue damage and the likelihood of amputations, while also assessing its impact on the long-term recovery of patients.

What is already known about the treatment

tPA
This medication is administered intravenously and is used in the treatment of severe frostbite injuries to the extremities. It is currently being studied in clinical trials to assess its effectiveness compared to other treatments. The main therapeutic indication is to improve blood flow and reduce tissue damage in frostbite cases. At the molecular level, tPA works by breaking down blood clots, which helps restore circulation to affected areas. It is classified as a thrombolytic agent.
Iloprost
This medication is administered intravenously and is used for treating severe frostbite injuries to the extremities. It is being evaluated in clinical trials to determine its efficacy in comparison to other treatments. The primary therapeutic indication is to enhance blood flow and prevent tissue damage in frostbite cases. Iloprost acts by dilating blood vessels and inhibiting platelet aggregation, improving circulation to the affected areas. It is classified as a vasodilator and antiplatelet agent.

Investigated diseases

Frostbite injury to extremities – Frostbite is a condition that occurs when skin and underlying tissues freeze due to exposure to extremely cold temperatures. It primarily affects the extremities, such as fingers, toes, ears, and nose. Initially, the skin becomes cold and red, then numb, hard, and pale. As the condition progresses, the affected area may blister and turn black as tissue damage occurs. Severe frostbite can lead to permanent damage, including the loss of fingers or toes. The progression of frostbite depends on the duration and severity of exposure to cold.