Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

This study is called "Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?" and is for people with leg ulcers that are caused by diabetes and a lack of blood flow (ischemic ulcers). Researchers want to find out if giving extra oxygen can help these ulcers heal better and, importantly, reduce the chances of needing a major amputation of the limb over a year. This is a Phase IV study, which means the treatment is already approved, and researchers are gathering more information on its long-term effects and how it works in real-world settings. They will be observing patients for 12 months to see the impact of oxygen treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC Stichting

Enrolment target

194

Start

18 Nov 2024

Symptomatic Ischemic Ulcer related to Diabetes

What is this study about?

You might have heard about this study, which is investigating a common and serious problem: leg ulcers related to diabetes and poor circulation. These ulcers can be very painful and difficult to heal, sometimes leading to serious complications. The study is particularly interested in 'ischemic ulcers,' which happen when there isn't enough blood flow to the area, often made worse by diabetes.

The main idea behind this research is to see if giving people extra oxygen can help these ulcers heal more effectively. Oxygen is vital for healing, and if an area isn't getting enough blood, it's also not getting enough oxygen. By increasing the oxygen, doctors hope to improve the healing process and, in doing so, reduce the need for more drastic treatments like major amputations.

This particular study is focusing on how well this oxygen treatment works over a longer period – specifically, 12 months. It's a 'Phase IV' study. This means the oxygen treatment being looked at is already a known therapy. Researchers are now carefully collecting more information about its benefits and any long-term effects, especially concerning how it might help reduce amputations.

Key takeaways

The study explores if extra oxygen helps diabetic leg ulcers.
It aims to reduce the need for major amputations.
Participation lasts for 12 months of follow-up.
Open to adults with specific diabetes-related ulcers.
Oxygen therapy is the main treatment being studied.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to be considered.

Since the study is about a specific health problem, you would need to have leg ulcers that are directly linked to diabetes and issues with blood flow. This means your doctor would have diagnosed you with what's called a 'symptomatic ischemic ulcer related to diabetes'.

Both men and women can participate in this study. The research team is looking for a diverse group of people to make sure the results are as widely applicable as possible.

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 a leg ulcer?
Has your doctor told you that your ulcer is linked to diabetes and poor blood flow (ischemic)?
Are you comfortable with a 12-month follow-up period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive oxygen therapy, which is the treatment being investigated. The details of how this oxygen is given (e.g., mask, type of oxygen) would be explained to you thoroughly by the study team. You would have regular visits with the study doctors and nurses, who would monitor your health and the progress of your ulcer.

These visits would include check-ups, assessments of your ulcer, and possibly other tests to see how your body is responding to the treatment. You would be followed by the study team for 12 months, meaning they would keep in touch with you and monitor your condition over this full year. This allows them to see the long-term effects of the oxygen treatment.

Potential risks and benefits

Taking part in this study might offer a potential benefit if oxygen therapy helps your ulcer heal better and reduces your risk of needing an amputation. While oxygen therapy is generally safe, there can be some minor risks or side effects, which the study team would discuss with you in detail. For example, some people might experience skin irritation where the oxygen is delivered. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Netherlands
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Unverified
Spain

Common questions

What is an 'ischemic ulcer'?

It's a type of sore, usually on the leg or foot, that develops because there isn't enough blood flowing to that area, often made worse by diabetes.

What does a 'Phase IV' study mean?

It means the treatment (oxygen) is already approved and used, but researchers are gathering more information about its long-term effects and how it works in a wider group of people.

Will I have to pay for the oxygen treatment?

Usually, in clinical studies, the study-related treatments are provided without cost to you, but you should confirm this with the study team.

How long will I be involved in the study?

You will be followed for 12 months to see the long-term effects of the oxygen treatment.

What is a 'major amputation'?

This refers to the removal of a limb, such as above or below the knee, due to severe damage or infection.