AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy of combined treatment by autologous cell therapy and percutaneous transluminal angioplasty (PTA) versus the treatment by isolated PTA in diabetic patients with chronic limb-threatening ischemia

This clinical trial is for people with diabetes who have very poor circulation in their legs, a condition called chronic limb-threatening ischemia. This can lead to serious problems like open sores that don't heal, and sometimes even the need for an amputation. The study wants to see if adding a treatment using the patient's own cells (taken from their bone marrow) to a standard procedure called angioplasty, works better than angioplasty alone. Researchers will be looking at important things like how many people need a major amputation, how well their wounds heal, and if blood flow improves.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institute For Clinical And Experimental Medicine

Enrolment target

110

Start

25 Feb 2025

chronic limb-threatening ischemia diabetic foot ulcers

What is this study about?

This study is about a serious problem called chronic limb-threatening ischemia, which often affects people with diabetes. This condition means that blood flow to the legs and feet is very poor, leading to wounds that don't heal, severe pain, and in some cases, the need for surgery to remove part of the leg (amputation).

Doctors already have a way to try and improve blood flow, called percutaneous transluminal angioplasty (PTA). This is a procedure where a tiny balloon is used to open up blocked blood vessels. This study is exploring if adding a new treatment to PTA could make it even more effective. The new treatment involves taking some of a patient's own bone marrow, separating out certain cells, and then giving these cells back to the patient. The idea is that these cells might help the body repair itself and grow new blood vessels, improving circulation further.

The main goal of this research is to see if combining the cell therapy with PTA can reduce the number of major amputations, help wounds heal better, and improve blood flow in the affected limb, compared to just having PTA on its own. This is a Phase II study, which means it's an early stage of testing to see if the new treatment is safe and shows promise.

Key takeaways

This study is for people with diabetes and severe leg circulation problems.
It aims to see if adding 'cell therapy' to a standard procedure (angioplasty) helps more.
The main goals are to reduce amputations and help wounds heal.
You might receive cell therapy or just angioplasty; it's decided randomly.
Taking part means regular check-ups to monitor your health and progress.

Who may be eligible?

This study is open to both men and women who are 18 years of age or older. There is no upper age limit for taking part.

To be considered for this study, you must have diabetes and also suffer from a severe circulation problem in your leg or foot. This condition is called chronic limb-threatening ischemia, and it means you have very poor blood flow that might be causing ongoing pain or wounds that aren't healing.

Your doctors will need to check other aspects of your health to make sure this study is right for you and that taking part would be safe. They will discuss all the requirements with you.

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 diabetes?
Have you been told you have very poor circulation in your leg or foot (chronic limb-threatening ischemia)?
Are you able to attend several follow-up appointments?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a detailed health check-up to ensure you meet all the requirements. You would then be randomly assigned to one of two groups: either you would receive the standard angioplasty treatment combined with the cell therapy, or you would receive angioplasty alone. You would have the angioplasty procedure, and if in the cell therapy group, the bone marrow collection and cell treatment would also be performed.

Throughout the study, you would have several follow-up visits. During these visits, doctors would check how well your wounds are healing, measure your blood flow using different methods, and ask about your pain levels and overall quality of life. They would also monitor you closely for any side effects or health changes. The total duration of your participation in the study would depend on how quickly your condition responds and the follow-up schedule, but typically clinical trials involve several appointments over many months.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your condition more effectively than current standard care, especially if the cell therapy proves successful. However, there are also risks, such as those associated with the angioplasty procedure itself, the bone marrow collection (if in that group), and the possibility of side effects from the cell therapy, some of which might be unexpected. It's important to remember that you have the right to 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
Czechia

Common questions

What is 'chronic limb-threatening ischemia'?

It's a serious condition where blood flow to your leg or foot is very poor. This can cause severe pain, wounds that don't heal, and sometimes even lead to amputation.

What is 'autologous cell therapy'?

It's a treatment where doctors take some of your own cells, in this case from your bone marrow, process them, and then put them back into your body to help with healing and repair.

What is 'PTA'?

PTA, or percutaneous transluminal angioplasty, is a common procedure where a thin tube with a tiny balloon is used to open up narrowed or blocked blood vessels to improve blood flow.

Will I definitely get the cell therapy?

No, you will be randomly assigned to one of two groups: either the standard angioplasty treatment plus the cell therapy, or the standard angioplasty treatment alone. This helps researchers compare the two approaches fairly.

How long does the study last?

The exact duration can vary, but generally, studies like this involve multiple appointments over several months to carefully monitor your progress and check for any effects of the treatment.