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Study on the Safety of Leukocyte-Platelet Rich Fibrin for Patients with Critical Limb Ischemia

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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 studying a condition known as critical limb ischemia, which is a severe blockage in the arteries of the lower limbs that significantly reduces blood flow. The study will explore the use of a treatment called Leukocyte-Platelet Rich Fibrin (L-PRF). This treatment involves using a special suspension made from a protein called fibrin, which is introduced into the body through an injection into the muscle.

The main purpose of the study is to assess the safety of using L-PRF in treating critical limb ischemia. Participants in the study will receive either the L-PRF treatment or a placebo. The study will monitor participants over a period to observe any reactions or events that occur during the treatment and at the final visit. The study will also look at various outcomes, such as the rate of survival without amputation, the time it takes for blood flow to improve, and changes in quality of life.

Throughout the study, participants will undergo regular assessments to track their progress. These assessments will include imaging studies to check muscle blood flow, measurements of blood pressure in the limbs, and evaluations of any changes in the severity of their condition. The study aims to provide valuable information on the potential benefits and safety of using L-PRF for patients with critical limb ischemia.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the clinical trial, you will attend an initial visit. During this visit, the study team will review your medical history and confirm your eligibility based on the inclusion criteria. This includes having symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale, which is known as critical limb ischemia.
You will be asked to finalize the informed consent form (ICF) to participate in the study and agree to post-operative rehabilitation.
Step 2
Treatment administration
The treatment involves the use of leukocyte-platelet rich fibrin (L-PRF), which is a suspension administered through an intramuscular injection. This is done to help improve blood flow and promote healing in the affected limb.
The primary objective of the study is to assess the safety of using L-PRF in treating critical limb ischemia.
Step 3
Follow-up visits
You will have regular follow-up visits to monitor your progress and assess any adverse reactions or events. These visits are crucial for ensuring your safety and evaluating the effectiveness of the treatment.
During these visits, various assessments will be conducted, including imaging studies to evaluate muscle perfusion, and measurements of the ankle-brachial index, which compares blood pressure in your ankle and arm.
Step 4
Final visit
At the final visit, the study team will conduct a comprehensive evaluation of your condition. This includes assessing the primary endpoint, which is the type and frequency of any adverse reactions or events.
Secondary endpoints will also be evaluated, such as mortality rate, amputation rate, time to revascularization, amputation-free survival time, and changes in ischemia scores. Your quality of life score will also be assessed.

Who can join the trial?

5 criteria

Agree to complete and sign the informed consent form (ICF) for participating in the study and for post-operative rehabilitation.
Have symptoms of **occlusive atherosclerosis** in the arteries of the lower limbs, which means there is a blockage in the blood vessels. This should be at stages 4 and 5 on the **Rutherford scale**, which measures the severity of **critical limb ischemia**. This condition must be confirmed by a doctor through clinical examination and tests that measure blood flow.
Be between the ages of 18 and 89 years old.
Have no absolute contraindications, meaning there are no medical reasons that would completely prevent you from having **revascularization procedures**, which are treatments to restore blood flow to the affected limb.
Have an expected average survival time of more than 3 years. This means that the risk of dying during the operation should be less than 5%, and there should be more than a 50% chance of living for at least 2 more years. Patients who meet these criteria are considered to have a medium or high surgical risk.

Who cannot join the trial?

4 criteria

Patients who are not experiencing critical limb ischemia cannot participate. Critical limb ischemia is a severe condition where there is not enough blood flow to the legs or feet, causing pain and possibly leading to sores or wounds.
Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Participants who do not meet the gender requirements of the study cannot participate. The study is open to both male and female participants.
Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

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Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

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Investigated drugs

L-PRF is a therapy used in this clinical trial. It stands for leucocyte- and platelet-rich fibrin. This therapy involves using a special type of blood clot that is rich in white blood cells and platelets. These components are important because they help the body heal and form new blood vessels. In this trial, L-PRF is used to help improve blood flow in patients with critical limb ischemia, a condition where blood flow to the limbs is severely reduced. The therapy is applied after a procedure that opens up blocked blood vessels, with the goal of enhancing the body's natural healing process and promoting the growth of new blood vessels.

FIBRIN

What is already known about the treatment

Leucocyte- and Platelet-Rich Fibrin (L-PRF) – This medication is administered percutaneously, meaning it is introduced through the skin, and is used in the treatment of critical limb ischemia. Currently, L-PRF is being studied in clinical trials to evaluate its safety and effectiveness in promoting blood vessel growth and healing after endovascular procedures. The main therapeutic indication for L-PRF is to enhance blood flow and tissue repair in patients with critical limb ischemia. At the molecular level, L-PRF works by releasing growth factors from platelets and white blood cells, which stimulate the formation of new blood vessels and tissue regeneration. It is classified pharmacologically as a biological product used in regenerative medicine.

Investigated diseases

Critical Limb Ischemia – Critical limb ischemia is a severe obstruction of the arteries that significantly reduces blood flow to the extremities, particularly the legs and feet. It is characterized by chronic pain in the legs and feet, even when at rest, and can lead to non-healing wounds or ulcers. The condition progresses as the blood supply becomes increasingly restricted, leading to tissue damage and potentially gangrene. Over time, the lack of adequate blood flow can cause the affected tissues to deteriorate, resulting in severe pain and potential loss of function in the limb. The progression of critical limb ischemia can lead to significant complications if not managed appropriately.