Not yet recruitingNAINTERVENTIONAL

A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers

This research is looking at two types of compression bandages, called Mepi Press 2 and UrgoK2, which are used to treat venous leg ulcers. These ulcers are common and can be challenging to manage, so effective treatment is very important. The main goal of this study is to find out if the Mepi Press 2 system is just as effective as the UrgoK2 system in helping these ulcers heal fully within 12 weeks. Researchers will evaluate how well each bandage works, how safe it is, and its overall performance. Adults with venous leg ulcers that have been present for less than two years are invited to participate in this study, which is taking place in France.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Molnlycke Health Care AB

Enrolment target

386

Start

01 May 2026

Estimated completion

01 May 2028

Venous Leg Ulcer (VLU)Compression Bandages

What is this study about?

Venous leg ulcers are a common type of sore on the lower leg, affecting many people. They happen when the veins in your legs don't work as well as they should, leading to blood pooling and pressure build-up. This can be painful and impact daily life, so finding the best ways to treat them is really important both for patients and healthcare services.

The usual and most effective treatment for these ulcers is 'compression therapy'. This means using special bandages to apply pressure to the leg. This pressure helps improve blood flow, reduce swelling, and create better conditions for the ulcer to heal. There are different types of compression bandages, and multi-layered systems (like having a few layers of bandages) are considered the most effective.

This study is comparing two specific multilayer compression bandage systems: Mepi Press 2 and UrgoK2. UrgoK2 is already widely used and considered a standard treatment. The researchers want to see if Mepi Press 2 works just as well as UrgoK2 in helping ulcers heal completely within 12 weeks. They will be looking at how many ulcers heal, how safe each bandage is, and how they perform overall.

Key takeaways

The study compares two compression bandage systems for leg ulcers.
It aims to see if Mepi Press 2 works as well as UrgoK2.
Participation involves wearing bandages and having regular check-ups.
The study lasts up to 12 weeks or until your ulcer heals.
Compression therapy is a key treatment for leg ulcers.
Your safety and wound healing will be closely monitored.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over. You must have a venous leg ulcer that was diagnosed less than two years ago. Your ulcer should be a certain size, not too small (at least 2 square centimetres) and not too large (no more than 40 square centimetres).

Doctors will also check your ankle-brachial pressure index (ABPI). This is a measurement that helps them understand your blood flow, and it needs to be within a specific range (between 0.8 and 1.3) to make sure compression therapy is safe and suitable for you. You also need to be able to speak and understand French as the study is taking place in France, and you must have health insurance coverage there.

There are also some reasons why you wouldn't be able to join. For example, if you have a known allergy or problem with either of the bandages being tested, or if you've recently had certain leg vein treatments or chemotherapy. If your wound is infected or you're pregnant or breastfeeding, you also won't be able to take part. Finally, if your doctor believes for any other reason that the study isn't right for you, you wouldn't be included.

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 venous leg ulcer that started less than two years ago?
Is your ulcer between 2 and 40 square centimetres in size?
Do you have suitable blood flow in your legs (as determined by a doctor)?
Are you able to speak and understand French?
Are you *not* pregnant or breastfeeding, and haven't had recent chemotherapy or leg vein surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of the two compression bandage systems – either Mepi Press 2 or UrgoK2 – just like you would normally be treated. Before the compression bandage is applied, an appropriate wound dressing will be put on your ulcer.

You will need to attend up to five study appointments over a maximum period of 12 weeks, or until your ulcer heals completely, whichever happens first. During these visits, the medical team will check how your wound is healing, ensure the bandages are performing well, and monitor you for any safety concerns or side effects. The total duration of your participation will depend on how quickly your ulcer heals, but it won't be longer than 12 weeks.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving close monitoring and care for your venous leg ulcer, potentially leading to healing. However, as with any medical treatment, there could be risks, such as skin irritation or discomfort from the bandages, though these systems are generally well-established. It’s important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Clinique du Parc-Montpellier
Verified postcode
Castelnau-le-Lez, France
CHU Michallon Grenoble
Verified postcode
Grenoble, France
Clinique du Parc Lyon
Verified postcode
Lyon, France
Hopital Edouard Herriot_HCL
Verified postcode
Lyon, France
CHU Nantes
Verified postcode
Nantes, France
Poitiers Polyclinique
Verified postcode
Poitiers, France
CHU Toulouse/Hopital Rangueil
Verified postcode
Toulouse, France
Clinique Pasteur-Toulouse
Verified postcode
Toulouse, France

Common questions

What is a venous leg ulcer?

It's a persistent sore on your lower leg that happens when veins don't return blood to your heart properly, causing pressure and damage to the skin.

What is 'compression therapy'?

It's a treatment where special bandages are used to apply pressure to your leg. This helps improve blood flow, reduce swelling, and aid healing.

Why are they comparing two bandages?

Researchers want to see if a newer bandage, Mepi Press 2, works just as well as an existing standard one, UrgoK2, to give patients more effective treatment options.

How long will I be in the study?

You'll be in the study for a maximum of 12 weeks, or until your ulcer heals, whichever comes first.

Can I choose which bandage I get?

No, like many studies, you would be randomly assigned to receive either the Mepi Press 2 or UrgoK2 system.

How to find out more

Clinical Project Manager

kristina.welinder@molnlycke.com +46 (0)31- 722 31 96 Official trial record

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