AuthorisedPhase II and Phase III (Integrated)Interventional

Prospective, multi-center, randomized, double-blinded, placebo-controlled phase IIb clinical trial to evaluate safety and efficacy of DUOFAG® in bacterial infection treatment in patients with complicated wounds

This research study is investigating a new treatment called DUOFAG for people with complicated skin wounds that are infected with specific bacteria, such as S. aureus and P. aeruginosa. These wounds can be from surgery, injuries, or long-lasting sores. The study wants to find out if DUOFAG is safe to use and if it can effectively get rid of the bacteria in the wound and help it heal better. It’s a ‘double-blind’ study, meaning neither you nor your doctor will know if you're receiving DUOFAG or an inactive liquid (like salt water) — this helps make the results fair and accurate. Participants will be carefully monitored for any side effects and how their wounds are healing and clearing up the infection.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

MB PHARMA s.r.o.

Enrolment target

100

Start

09 Feb 2026

Complicated skin wounds (wounds healing per secundam via granulation tissue) - either as a complication of healing of acute wounds (infected surgical or traumatic wounds) or chronic wounds in both cases infected with S. aureus and/or P. aeruginosa.

What is this study about?

This study is looking into a new treatment called DUOFAG for people who have complicated skin wounds. These are wounds that aren't healing easily, perhaps after an operation or an injury, or they might be long-term sores. A key part of these wounds is that they are infected with specific types of bacteria, mainly S. aureus and P. aeruginosa.

The main goals are to check if DUOFAG is safe to use and if it effectively helps to clear up these bacterial infections in the wounds. We also want to see if it helps the wounds heal better overall. To do this, some people in the study will receive DUOFAG, while others will get a plain salt water solution (which acts as a 'dummy' treatment, also known as a placebo). This comparison helps us understand if DUOFAG is truly making a difference.

This is a 'phase II and III' study, which means it’s an integrated step in testing new medicines. Phase II focuses on further checking the safety of the treatment and finding the right dose, while Phase III looks at how well the treatment works compared to existing options or a placebo, and confirms its safety in a larger group of people. By combining them, researchers aim to gather information more efficiently.

Key takeaways

The study is testing a new treatment called DUOFAG for infected skin wounds.
It aims to see if DUOFAG is safe and effective against specific bacteria (S. aureus and P. aeruginosa).
You might receive DUOFAG or a plain salt water solution as a comparison.
Participation involves receiving treatment and having your wound regularly checked.
The study is for adults aged 18 and over with specific types of infected wounds.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older – there's no upper age limit.

The main requirement for your health is that you must have a complicated skin wound. This wound needs to be healing in a specific way, often called ‘healing by granulation tissue’, meaning it's filling in from the bottom up. Crucially, your wound must also be infected with specific bacteria, either S. aureus or P. aeruginosa, or both.

These wounds could be a problem following surgery or a serious injury, or they could be wounds that have been ongoing for a longer time.

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 complicated skin wound (not healing easily)?
Has your wound been confirmed to be infected with S. aureus and/or P. aeruginosa bacteria?
Is your wound from surgery, an injury, or is it a long-standing sore?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive either the DUOFAG treatment or a plain salt water solution. This will be given to you over a period of up to 14 days. During this time, and for a period afterwards, the study team will closely monitor your wound and your general health. This will involve regular check-ups, where they will look at your wound, ask you how you are feeling, and take swabs from your wound to see if the bacteria are still present or if they've gone away. They will also keep an eye out for any side effects you might experience. The total duration of your participation, including follow-up, will be explained to you by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option for your infected wound that isn't yet widely available. However, there's no guarantee that DUOFAG will work for everyone, as it is still being tested. Like all treatments, DUOFAG may have side effects, which could be local (at the wound site) or affect your body generally. These will be carefully explained to you by the medical 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
Czechia

Common questions

What kind of wounds is this study for?

This study is for complicated skin wounds that are infected with specific bacteria like S. aureus or P. aeruginosa. These could be wounds after surgery, injuries, or long-lasting sores.

What is DUOFAG?

DUOFAG is a new treatment being tested to see if it can safely and effectively clear bacterial infections in complicated wounds and help them heal.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're receiving DUOFAG or the plain salt water solution. This helps ensure the study results are unbiased and accurate.

How long will I be in the study?

You'll receive the treatment for up to 14 days, and then you'll have follow-up visits. The study team will explain the full duration of your involvement.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your future medical care.