AuthorisedTherapeutic use (Phase IV)Interventional

Prospective Randomised Nordic Frostbite Treatment Study comparing tPA and iloprost therapy

This study aims to discover the most effective treatment for severe frostbite, particularly in fingers and toes. When people get severe frostbite, sometimes the affected body parts can't be saved, and doctors might need to perform an amputation. This research is comparing two different medicines, alteplase and iloprost, to see which one works better at limiting the damage and helping to save as much of the affected area as possible. Both medicines are already approved for other uses. Doctors involved in this study want to understand if one of these treatments can significantly reduce the number of people who need amputations due to frostbite. This is an important step in improving how we care for people with this serious injury.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

100

Start

30 Jan 2025

Frostbite injury to extremities

What is this study about?

When someone gets really bad frostbite, especially on their fingers or toes, it can be a very serious injury. In some cases, the damage is so severe that parts of the body might not recover, and doctors have to consider an amputation (surgery to remove the damaged part). This study is trying to find the best way to treat severe frostbite to avoid this.

The study is comparing two different medicines: alteplase and iloprost. Both of these medicines are already used in healthcare for other conditions. Researchers want to see if one of them is more effective than the other in helping to save fingers, toes, or other affected body parts from needing to be amputated after frostbite. By comparing them directly, doctors hope to learn which treatment can offer the best chance of recovery for patients with this type of injury and reduce the need for surgery.

This type of study is called a 'Phase IV' study. This means the medicines being tested are already approved for use, but doctors are looking closely at how they work for a specific condition (severe frostbite) and comparing them head-to-head. The main aim is to improve the care for people who suffer from severe frostbite, giving them the best possible outcome and helping them keep their fingers and toes.

Key takeaways

The study compares two existing medicines (alteplase and iloprost) for severe frostbite.
The main goal is to see which medicine best prevents the need for amputations.
Participants must be 18 or older with severe frostbite in their extremities.
It's a 'Phase IV' study, meaning medicines are already approved for other uses.
Your treatment will be closely monitored by medical professionals.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To join this study, people must be at least 18 years old. There's no upper age limit, so older adults can also take part. The study needs people who have severe frostbite affecting their hands or feet, like their fingers or toes. It's important that the frostbite is severe enough to warrant the kind of treatment being studied.

The study includes both men and women. If you have had previous health conditions or are taking certain medications, the study doctors would review your health information to make sure it's safe for you to participate. They want to ensure the study is right for you and that you meet all the specific requirements designed to keep participants safe and get clear results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe frostbite affecting your fingers, toes, or other extremities?
Are you able to understand and agree to participate in the study?
Are you willing to follow the study's treatment and follow-up plan?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to receive one of the two medicines being tested: either alteplase or iloprost. This means you wouldn't get to choose which medicine you receive, similar to flipping a coin. You would receive your treatment and be closely monitored by a team of doctors and nurses while you are in the hospital. The medical team would regularly check your health, how your frostbite is healing, and if you are experiencing any side effects from the medication.

After your initial treatment, you would likely have follow-up visits to check on your recovery. These visits might involve physical examinations and possibly imaging scans (like X-rays) to see how your fingers or toes are healing. The total duration of your participation in the study, including treatment and follow-up, would depend on your individual recovery, but the doctors will explain the expected timeline to you.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving one of two treatments that doctors believe could help save your fingers or toes from amputation. However, as with any medical treatment, there are potential risks and side effects associated with both medicines. These will be fully explained to you by the medical team. You are always free to ask questions or withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is frostbite?

Frostbite is a serious injury that happens when skin and other tissues freeze from being in very cold temperatures. It most often affects fingers, toes, ears, and the nose.

What is an amputation?

An amputation is surgery to remove a body part, such as a finger or toe, when it is so severely damaged that it cannot heal or is causing serious health problems.

Are the medicines in the study new?

No, both alteplase and iloprost are medicines already approved and used for other conditions. This study is testing how well they work for severe frostbite.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or any related medical care while participating in the study.

What if I get worse during the study?

You will be closely monitored by medical staff. If your condition worsens or you experience any severe side effects, they would adjust your care as needed, and you can withdraw from the study at any time.