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Not yet recruitingNAINTERVENTIONAL

Use of CPETarm for Risk Stratification of Patients With CLTI

This study is for people in the UK with a serious leg condition called Chronic Limb-Threatening Ischemia (CLTI), which causes severe pain and tissue damage. Many of these patients need urgent surgery, but their existing health issues can make these operations risky. Researchers are testing a new exercise assessment called CPETarm. Instead of a bike, it uses an arm machine to check heart and lung fitness quickly before surgery. The goal is to see if this test can help doctors better understand a patient's risks, leading to safer surgeries, fewer complications, and better overall outcomes. Patients will be followed for up to five years to see the long-term benefits.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
University of Manchester
Enrolment target
120
Start
28 May 2024
Estimated completion
28 Apr 2030
Chronic Limb-Threatening IschemiaSurgery-Complications

What is this study about?

This study is about a serious health condition known as Chronic Limb-Threatening Ischemia, or CLTI for short. This happens when blood flow to your legs is very poor, causing pain even when you're resting, and sometimes leading to wounds or sores that don't heal. It's a growing problem in the UK, often linked to an ageing population and common conditions like diabetes.

Many patients with CLTI need surgery, sometimes very urgently. However, these patients often have other health problems, such as high blood pressure or heart disease, which can make surgery riskier. Doctors need to quickly understand a patient's overall health to plan the safest treatment, but this can be hard when someone needs an urgent operation. Without this information, there can be delays, longer hospital stays, and a higher chance of complications or even losing a limb.

Currently, there isn't a good, quick way to assess the risks for CLTI patients who need emergency surgery. This study is testing a special exercise test called Cardiopulmonary Exercise Testing, or CPET. Normally, CPET involves cycling on a stationary bike, which isn't suitable for people with leg problems. So, this study is trying a new version called CPETarm, where you use your arms on an exercise machine instead. The main aim is to see if this arm exercise test can be done quickly and safely by the bedside within 48 hours for patients needing surgery, helping doctors make better decisions about their care.

Key takeaways

  • Tests a new arm exercise to assess fitness before urgent leg surgery.
  • Aims to make surgery safer for patients with poor leg circulation (CLTI).
  • Looks at heart and lung health using an arm machine instead of a bike.
  • Could help doctors better plan care and reduce risks.
  • Participation involves one exercise test and long-term health tracking.
  • Doesn't involve new medications, only a diagnostic test.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have been diagnosed with a severe leg circulation problem called chronic limb-threatening ischemia (CLTI). You would need to be planning to have one of several specific leg surgeries or a primary amputation related to this condition. It's also important that you are able to understand the study and agree to take part in writing.

However, there are reasons why you might not be able to join. For example, if you have certain active heart problems that would make exercise testing unsafe, or if you are currently being treated or waiting for tests for heart conditions like blocked arteries or irregular heartbeats. If you have severe heart valve problems or active heart failure that needs urgent medication changes, you would also likely not be able to participate. Similarly, if a physical problem stops you from doing the arm exercise test, or if a memory problem or mental health condition prevents you from giving consent or attending follow-up appointments, you would not be eligible.

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.

  1. Are you 18 or older?
  2. Do you have severe leg circulation problems (CLTI) and need related surgery or amputation?
  3. Can you give your written consent to join the study?
  4. Do you have any current active heart conditions that might make exercise unsafe?
  5. Are you able to use an arm exercise machine?
Answer every question to see your result.

What does participation involve?

If you join this study, before your surgery, you will have a special arm exercise test called CPETarm. This test is similar to cycling, but you'll use your arms instead. The team will record how you manage during this test.

After your surgery, the study team will keep in touch to see how you are doing for up to five years. They will collect information about your health and recovery, such as whether you needed to stay in hospital longer, if you had any complications, or about your general well-being. There are no new medications involved in this study; it's about seeing if the arm exercise test provides helpful information for your doctors. The total duration of your involvement could be up to five years, simply because your health outcomes will be monitored over that period.

Potential risks and benefits

Participating in this study might offer the benefit of a more thorough and perhaps safer assessment before your surgery, potentially leading to better planning for your care. While the arm exercise test is generally considered safe, there's a small risk of feeling tired or experiencing discomfort during the exercise, similar to any physical activity. All tests will be supervised by trained medical staff to ensure your safety. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Manchester
    Verified postcode
    Manchester, United Kingdom

Common questions

What is Chronic Limb-Threatening Ischemia (CLTI)?

CLTI is a serious condition where there’s very poor blood flow to your legs, causing severe pain even when resting, and potentially leading to wounds that don't heal.

What is CPETarm?

CPETarm is an exercise test using an arm machine, similar to a bike but for your arms. It helps doctors assess your heart and lung fitness quickly and safely.

Why can't I do the usual exercise test?

The traditional CPET test uses a stationary bike, which isn't suitable for people with leg problems like CLTI, especially before surgery.

How long will I be involved in the study?

After your arm exercise test before surgery, we will follow your progress and health outcomes for up to five years.

Will taking part change my surgery plan?

The aim is for the CPETarm results to help doctors make more informed decisions about your care and surgery plan, potentially improving safety and outcomes.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Use of CPETarm for Risk Stratification of Patients With CLTI…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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