Active not recruitingNAINTERVENTIONAL

Shockwave Therapy in Lower Limb Intermittent Calf Claudication

This study is exploring a new treatment called shockwave therapy for people who experience leg pain when walking, a condition often called "intermittent claudication." This pain happens because blood flow to the calf muscles is reduced due to a common condition affecting many older adults. Shockwave therapy has previously shown promise in encouraging new blood vessel growth and healing. This study aims to find out if applying shockwaves to the calf muscles can improve blood supply, reduce pain, help people walk further, and generally improve their quality of life. We'll be comparing this treatment to a 'sham' treatment to truly understand its effects.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

138

Start

11 May 2015

Estimated completion

01 Feb 2030

Peripheral Vascular Disease

What is this study about?

You might be interested in this study if you experience pain in your calf muscles when you walk, which typically eases when you rest. This is often caused by a condition called Peripheral Arterial Disease (PAD), where your legs don't get enough blood supply. It can be quite limiting and affect your daily life.

Researchers are investigating whether a treatment called shockwave therapy could help. This therapy works by sending sound waves to a specific area. Previous studies have suggested it might help the body grow new blood vessels and encourage healing. In this study, we want to see if these shockwaves, when aimed at the calf muscles, can improve blood flow.

The main goal is to find out if this improved blood flow could lead to less pain when walking, help you walk longer distances, and ultimately improve your overall quality of life. We'll compare the shockwave treatment to a 'dummy' treatment to make sure any improvements are truly due to the therapy itself.

Key takeaways

Tests shockwave therapy for leg pain caused by poor circulation.
Aims to improve walking distance, reduce pain, and boost quality of life.
Compares real treatment to a dummy 'sham' treatment.
Regular assessments will track changes in walking and well-being.
Participation requires stable leg pain and current standard medications.

Who may be eligible?

To join this study, you need to be an adult (18 or older) and capable of understanding what the study involves and agreeing to take part. You must also be able to attend all your appointments throughout the study and follow the study's instructions carefully.

Your leg pain from walking should have been stable for the last three months, and you should already be taking standard medications for your condition, such as anti-platelet drugs and statins. This study is suitable for people with this type of leg pain in one or both legs.

However, you won't be able to join if you have cancer, are pregnant, are allergic to anti-platelet drugs or statins, have metal implants near your treatment area, or take blood-thinning medicines like Warfarin.

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 get leg pain when walking that goes away with rest?
Has your leg pain been stable for the last 3 months?
Are you currently taking anti-platelet medicine and a statin?
Are you able to attend all study appointments?
Do you not have a metal implant near your calf?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll either receive the actual shockwave therapy or a 'sham' (dummy) treatment. Both involve a device being placed on your calf muscles for several minutes during each session. Trained staff will apply this, following careful instructions. If you're in the sham group, it will look and feel like treatment, but the shockwaves won't be active.

Before and after the treatment, you'll have several assessments. These will measure things like how far you can walk before pain starts, your maximum walking distance, and you'll fill out questionnaires about your quality of life. This helps the researchers understand if the treatment has made a difference. The total duration of your participation and the number of visits will be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part could include an improvement in your walking ability, a reduction in leg pain, and an overall better quality of life if the shockwave therapy proves effective. However, as this is a research study, there's no guarantee you will personally benefit. Potential risks are generally low, but might include some temporary discomfort during the treatment or minor skin irritation. You will be fully informed of all known potential side effects. Remember, participating is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

Academic Vascular Surgery Unit
Verified postcode
Hull, United Kingdom

Common questions

What is 'intermittent claudication'?

It's leg pain, usually in your calves, that starts when you walk and gets better when you rest. It's caused by not enough blood flow to your muscles.

What is shockwave therapy?

It's a treatment that uses sound waves focused on your calf muscles. We're studying if it can help improve blood flow.

Will I definitely get the real treatment?

You might get the real shockwave treatment or a 'sham' (dummy) treatment. This helps us fairly compare the effects. You won't know which one you get.

How long will the study appointments take?

The study team will tell you exactly how long each session will be and how many appointments you'll need to attend.

What if I change my mind about taking part?

You can leave the study at any time, for any reason, without it affecting your regular medical care.