Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Placebo-Controlled, Double-blind, Dose-Ranging, Multicenter, Phase IIb Clinical Trial to Investigate the Efficacy and Safety of allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer (CVU)

This clinical trial is investigating a new medication, allo-APZ2-CVU, for people with chronic venous ulcers (CVU) – these are leg sores that are difficult to heal. The study aims to find out if this new treatment is effective in helping these wounds close completely and stay closed for at least two weeks. Researchers will also be looking closely at any side effects to make sure the treatment is safe. Different amounts (doses) of the new medication are being tested against a placebo, which looks like the real treatment but contains no active medicine. This helps researchers understand the true effects of the new treatment. This is a Phase II study, meaning it’s an early stage of testing to see if the treatment works and is safe enough to study further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rheacell GmbH & Co. KG

Enrolment target

200

Start

06 Mar 2024

Chronic venous ulcers (CVU)

What is this study about?

You're probably here because you or someone you know has a chronic venous ulcer, a leg wound that just doesn't seem to heal. These can be really frustrating and painful. This study is testing a new treatment called allo-APZ2-CVU, which scientists hope might help these stubborn wounds finally close. They are comparing different amounts (doses) of this new treatment with a 'dummy' treatment, called a placebo, which looks exactly the same but doesn't contain any active medicine. This helps the researchers understand if the new treatment is truly effective or if any improvements are due to other factors.

The main goal of this trial is to see if the new treatment helps your wound close completely within 18 weeks and, importantly, whether it stays closed for at least two weeks afterwards. They will also be carefully monitoring for any unwanted effects or side effects to ensure the treatment is safe for people to use. Besides checking if the wound closes, the researchers will also measure how much the wound changes in size over time, how long it takes for a wound to close, and if a closed wound reopens. They'll also be looking at how the quality of your wound healing develops.

But it's not just about the wound itself. The researchers also want to understand how the treatment affects your daily life. They will ask you about your quality of life using special questionnaires and how much pain you might be feeling. All this information helps them build a complete picture of whether allo-APZ2-CVU could be a helpful new option for people struggling with chronic venous ulcers.

Key takeaways

This study is for difficult-to-heal leg ulcers.
It tests a new medicine against a dummy treatment.
The main goal is to see if wounds heal and stay closed.
Your pain and quality of life will also be tracked.
The study lasts at least 18 weeks, plus follow-up.
Your safety will be closely monitored throughout.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.

However, it's specifically for people who have chronic venous ulcers – these are leg ulcers caused by problems with blood flow in the veins that haven't healed despite other treatments. The medical team will check other specific health requirements to make sure the study is a good fit for you and safe for you to participate in.

Before you can join, a doctor involved in the study will review your medical history and current health to confirm if you meet all the necessary criteria. This is important for your safety and to make sure the study results are clear and accurate.

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 chronic venous ulcer (a long-lasting leg sore)?
Has your ulcer not healed well with other treatments?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to receive one of three different doses of the new treatment (allo-APZ2-CVU) or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind' and it helps ensure the study results are unbiased. You'll receive this treatment for a set period.

Throughout the study, you will have regular visits to the clinic so the medical team can monitor your wound healing, check your general health, and look for any side effects. These visits will involve assessments like measuring your wound, answering questionnaires about your pain and quality of life, and having physical examinations. The main part of the study will last for 18 weeks, during which your wound closure will be monitored closely. After this, there will be follow-up visits to see if your wound stays closed and to check for any long-term effects. The total duration of your involvement could extend beyond the initial 18 weeks due to these follow-up checks.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could help your chronic venous ulcer heal when other treatments haven't worked. You would also be contributing valuable information that could help others with similar conditions in the future. However, there's also a risk that the treatment might not work for you, or you might receive the placebo. There could also be side effects from the new treatment, which will be closely monitored by the study team. 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
Germany

Common questions

What is a chronic venous ulcer?

It's a long-lasting sore on your leg, usually caused by poor blood circulation in your veins, that doesn't heal easily with standard treatments.

What does 'placebo' mean?

A placebo is a 'dummy' treatment that looks exactly like the real medication but contains no active medicine. It helps researchers compare the effect of the new treatment fairly.

Will I know if I'm getting the new treatment or the placebo?

No, neither you nor your doctor will know. This is a common practice in studies to make sure the results are as accurate as possible.

How long will I be in the study?

The main part of the study where your wound healing is most closely watched lasts about 18 weeks, but there will be follow-up visits after that to check on your progress.

What if I decide I don't want to be in the study anymore?

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