Phase II/III randomized controlled open-label trial to evaluate the efficacy and safety of personalized tissue engineered veins in patients with chronic venous insufficiency
This research is looking into a new way to treat persistent leg vein issues, a condition called chronic venous insufficiency. The study will test a special, 'personalised' vein replacement made from your own body's building blocks. Researchers want to see if this new vein replacement can help improve how well the valves in your leg veins work and reduce uncomfortable symptoms like swelling and pain over six months, compared to receiving usual care. They will also be carefully checking for any side effects. This trial includes both a smaller early stage and a larger main stage, aiming to get a good understanding of both the effectiveness and safety of this new treatment for adults.
At a glance
What is this study about?
This study is designed for people who have chronic venous insufficiency. This is a condition where the valves in the veins of your legs don't work properly, making it hard for blood to flow back up to your heart. This can lead to symptoms like aching, swelling, changes in skin, and sometimes even leg ulcers.
The researchers are testing a new kind of treatment called a 'Personalized Tissue Engineered Vein' (P-TEV). This is a specially made vein that is designed to replace or help the faulty valves in your own leg veins. Doctors want to find out if putting in this new vein replacement can make the valves work better and reduce your symptoms, compared to people who don't have this procedure. They will be comparing how well people do after getting the P-TEV to those who receive standard care.
The main things they will be checking are how well the valves in your leg veins are working after six months (using a special ultrasound scan) and if there's a significant improvement in your leg symptoms. They will also look at other factors like how quickly ulcers heal, improvements in your quality of life, and keeping a close eye on any side effects to make sure the treatment is safe.
Key takeaways
- Tests a new personalised vein treatment for chronic leg vein problems.
- Compares the new treatment to standard care.
- Aims to improve valve function and reduce symptoms.
- Involves regular check-ups over 12 months.
- Participants are randomly assigned to treatment groups.
- Carefully monitors for safety and effectiveness.
Who may be eligible?
This study is for adults generally aged 18 and over, both men and women, who have chronic venous insufficiency.
To be considered, your leg vein problems must be ongoing and typically severe enough that your doctor believes you could benefit from this new treatment option. This means you would likely have noticeable symptoms related to your leg veins.
There will be other specific medical checks to make sure this study is right for you and that you can safely take part. These checks will be done by the study doctors after you express an interest.
- Are you 18 years old or older?
- Do you have chronic venous insufficiency (ongoing leg vein problems)?
- Are you generally in good enough health to consider a medical procedure?
- Are you able to attend regular follow-up appointments for a year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would be randomly assigned to either receive the new personalised vein treatment or continue with standard medical care for your chronic venous insufficiency. Being 'randomly assigned' means it's like flipping a coin – neither you nor your doctor chooses which group you're in. This helps make the study fair.
If you receive the new vein treatment, it would involve a surgical procedure to implant the personalised replacement vein. Throughout the study, you would have several appointments over 12 months (at 1, 3, 6, and 12 months after starting the study) where doctors will check your progress. These check-ups might include special ultrasound scans to look at your veins, measurements of your legs, and questionnaires about your symptoms and how you're feeling generally. Researchers will also carefully monitor any side effects from the treatment or procedure. The total duration of active participation in the study for monitoring would be at least 12 months.
Potential risks and benefits
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Common questions
What is chronic venous insufficiency?
It's a common condition where the valves in your leg veins don't work well, making it hard for blood to return to your heart. This can cause swelling, pain, and skin changes in your legs.
What is a 'Personalized Tissue Engineered Vein' (P-TEV)?
It's a specially made replacement vein designed to help or replace the faulty valves in your legs, potentially improving blood flow and reducing symptoms.
Will I definitely get the new treatment if I join?
No, this is a 'randomised' study. This means you'll be assigned by chance (like a coin toss) to either receive the new treatment or to continue with standard care for comparison.
How long would I need to be involved in the study?
You would be monitored for at least 12 months with several check-up appointments to track your progress and well-being.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any point, and it won't affect your ongoing medical care or relationship with your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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