Ongoing Clinical Trials for Frostbite
There is currently one ongoing clinical trial investigating treatments for severe frostbite injury affecting the extremities. This trial is comparing two medications—alteplase (tPA) and iloprost—to determine which is more effective at reducing the need for amputations and improving recovery outcomes in patients with severe frostbite.
Clinical trial locations
Study on Frostbite Treatment for Severe Cases Using Alteplase and Iloprost
This clinical trial is focused on treating severe cases of frostbite, which is an injury caused by freezing of the skin and underlying tissues. Frostbite typically affects the extremities such as fingers, toes, ears, and nose. When exposed to extremely cold temperatures, the skin first becomes cold and red, then numb, hard, and pale. As the condition worsens, blisters may form and the affected area can turn black due to tissue damage. In severe cases, frostbite can lead to permanent damage and may require amputation of affected body parts.
The study compares two different treatments: alteplase (also known as tPA) and iloprost. Alteplase is delivered directly into an artery (intra-arterially), while iloprost is given through an intravenous infusion into a vein. The main goal is to determine whether iloprost is as effective as alteplase in treating severe frostbite.
Inclusion criteria: To participate in this trial, patients must have severe frostbite affecting the distal extremities (the parts of the body farthest from the center, such as fingers and toes). Participants must be between 18 and 64 years of age. Both men and women can join the study. Patients should not belong to a vulnerable population that requires special protection or care.
Exclusion criteria: Patients who do not have severe frostbite injury to their arms or legs cannot participate. Those who fall outside the specified age range are also excluded. Additionally, individuals who are part of a vulnerable population, such as those unable to make decisions for themselves, cannot take part in the trial.
Focus and goals: The trial follows a structured approach. Upon enrollment, patients with severe frostbite in the extremities are randomly assigned to receive either alteplase or iloprost. This randomization ensures that the study results are unbiased. The treatment is then administered according to the assigned group—alteplase directly into an artery or iloprost into a vein. Throughout the treatment, researchers collect data on the patient’s response, including changes in the condition of the affected extremities.
The primary outcome being assessed is the level of amputation required, if any. This helps determine how effective each treatment is at preserving tissue and avoiding amputation. Secondary outcomes include long-term functional recovery and various blood-related measurements taken before and after treatment. Patients are monitored over time to evaluate how well they recover and regain function in the affected areas.
Investigational drugs: The trial is testing two medications. Alteplase (tPA) is a medication that helps dissolve blood clots. By breaking down clots, it helps restore blood flow to the affected areas, which may reduce tissue damage and the need for amputations. It is classified as a thrombolytic agent. Iloprost is a medication that widens blood vessels and improves blood flow. It works by dilating blood vessels and preventing platelets from sticking together, which enhances circulation to the damaged tissue. It is classified as a vasodilator and antiplatelet agent.
The study aims to include at least 50 participants to ensure reliable and meaningful results. By comparing these two treatments, researchers hope to identify the best approach to reduce amputations and improve recovery for those suffering from severe frostbite.
Summary
Currently, there is one ongoing clinical trial investigating treatments for severe frostbite. This trial is taking place in Finland and is comparing two medications—alteplase and iloprost—to see which one is more effective at preventing amputations and improving long-term recovery. Both drugs work by improving blood flow to the frozen tissues, but they are delivered in different ways. The trial is enrolling adults aged 18 to 64 who have severe frostbite affecting their fingers, toes, or other extremities. The study aims to provide important evidence to help doctors choose the best treatment for this serious cold-related injury.
