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Safety and efficacy of elfucose, d‑galactose and polyhexanide solution 20% in patients with chronic wounds colonized by Pseudomonas aeruginosa

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves adults with a chronic wound that is colonized by the bacterium Pseudomonas aeruginosa. These wounds are long‑lasting skin injuries that have not healed and have bacteria living on them. The trial compares a new topical powder containing the substances elfucose and d-galactose, identified as PB-TX-01, with an existing liquid wound cleanser that contains polyhexanide solution 20% and is marketed as Serasept® 2 Antiseptische Lösung. The purpose of the study is to determine whether the new powder is safe and works better than the existing cleanser in reducing the bacterial load and improving wound healing.

Participants are randomly assigned to receive either the powder or the liquid, which are applied to the wound once daily for about two weeks. Swab samples are taken from the wound before treatment and after 14 days to check how many bacteria are present. Safety is checked by recording any side effects or problems that happen during the 90‑day follow‑up period, and the size of the wound and the amount of pain are also observed. The study does not involve any invasive procedures and follows the participants for up to three months after the treatment starts.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and assignment

    After joining the study, you will be randomly placed into one of two groups. one group receives the test product pb-tx-01 and the other group receives the comparator product serasept. the assignment is done by the study staff and you will not know which product you receive.

  2. Step 2

    Baseline assessment

    Before any medication is applied, the study team will examine your wound, measure its size, and take a swab to determine the amount of pseudomonas aeruginosa bacteria present.

    You will also be asked to rate any pain you feel using a simple scale, and you will complete short questionnaires about your overall health and quality of life.

  3. Step 3

    Start of treatment

    You will begin the topical application of the assigned medication to the wound.

    If you are in the pb-tx-01 group, you will apply 2 g of the powder to the wound each day.

    If you are in the serasept group, you will apply 10 ml of the solution to the wound each day.

    The medication should be applied exactly as instructed by the study staff and continued for at least 14 days.

  4. Step 4

    Daily wound care

    Each day you will clean the wound according to the instructions and then apply the medication.

    You should note any changes in pain, redness, swelling, or other symptoms and report them at the scheduled visits.

  5. Step 5

    Day 14 follow‑up visit

    After 14 days of treatment, you will return for a follow‑up visit.

    The study team will take another swab to check how much pseudomonas aeruginosa is left, measure the wound size again, and ask you to rate pain and any signs of infection.

    The results will be used to see whether the bacterial load has decreased compared with the baseline measurement.

  6. Step 6

    Ongoing safety monitoring

    You will continue to use the medication as instructed until day 90.

    Additional visits or telephone contacts are planned on day 29 to complete quality‑of‑life questionnaires, and on day 90 for a final safety check.

    During this period you should report any side effects, new symptoms, or concerns to the study staff.

  7. Step 7

    Final assessment

    On day 90, a final assessment will be performed.

    The wound will be measured again, and the study team will collect information about any adverse events that occurred during the trial.

    All data will be reviewed to determine the overall safety and effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Be at least 18 years old when you sign the study paperwork.
  • Have a chronic wound (a wound that has been present for at least 6 weeks) that is colonized by Pseudomonas aeruginosa – this means the bacteria P. aeruginosa is found in the wound. Other bacteria may also be present, as long as P. aeruginosa is there.
  • Be able to come in for daily dressing changes while you are using the study treatment.
  • Be capable of reading, understanding, and signing the informed consent form, which explains the study, its risks, and what you will experience.
  • If you are a woman, you must either use a highly effective method of birth control and continue it for the whole study period, or have proof that you cannot become pregnant (known as non‑childbearing potential).

Who cannot join the trial?

14 criteria

  • If you are known or thought to be allergic (have an immune reaction that can cause rash, itching, or swelling) or overly sensitive to the study drug, its ingredients, or the bandage materials, you cannot join.
  • If you have taken part in another clinical trial within the last four weeks before screening, you cannot join.
  • If you might be unreliable, untrustworthy, or unable to follow the study rules, you cannot join.
  • If you might engage in self‑harmful behavior (such as self‑injury or self‑manipulation), you cannot join.
  • If you are closely related to the study doctor, staff, or sponsor (for example, a family member), you cannot join.
  • If you are living in an institution because of a legal or regulatory order (for example, jail or mandated care), you cannot join.
  • If you are taking systemic antibiotics (antibiotics taken by mouth or injection that affect the whole body) within two weeks before screening or during the treatment period, you cannot join, except for antibiotic creams used for other reasons.
  • If you have a birth‑related disorder that affects how your body processes a sugar called D‑galactose (such as galactosemia), you cannot join.
  • If your immune system is very weak (severely immunocompromised) because of a primary immune deficiency, chemotherapy (cancer‑treating medicine), organ transplantation, or medicines that suppress immunity, you cannot join, except for topical steroid creams used for other reasons.
  • If you have been diagnosed with sepsis (a serious body‑wide infection) within two weeks before screening or during the treatment period, you cannot join.
  • If you have a planned surgery (except minor outpatient surgery) within two weeks before screening or during the treatment period, you cannot join.
  • If you are pregnant or nursing (breastfeeding) during the study period, you cannot join.
  • If the wound being studied is larger than 50 cm² (including a small border of 0.5 cm around it), you cannot join.
  • If you have another wound close to the study wound (less than 5 cm away or under the same dressing), you cannot join.
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Investigated drugs

  • Serasept® 2 Antiseptische Lösung

    is a liquid antiseptic that is put directly on the wound. It contains a substance called polyhexanide, which helps kill bacteria that may be living in the wound. In this study it is used as the standard treatment (comparator) so the researchers can see how the new product compares to an already‑available wound cleanser.

  • PB-TX-01

    is a powder that is applied to the wound surface. It is made from two sugars, elfucose and d‑galactose, that are thought to interfere with the growth of the bacterium Pseudomonas aeruginosa, a common cause of chronic wound infection. This product is the experimental (test) treatment whose safety and ability to lower bacterial numbers are being evaluated in the trial.

What is already known about the treatment

  • Serasept® 2 Antiseptische Lösung

    This medication is a clear liquid that is applied directly to the wound surface, usually by pouring or spraying a measured amount. It contains a 20 % solution of polyhexanide, an antiseptic that is already approved and widely used in many countries for cleaning wounds. Polyhexanide works by breaking down the bacterial cell membrane, which kills the germs and prevents them from growing. It is classified as a topical antiseptic (ATC code D08AC05) and is commonly used to treat infected or contaminated skin wounds.

  • PB-TX-01

    This product is a fine powder that is spread over the wound and then covered, delivering the active sugars elfucose and D‑galactose directly to the wound site. The ingredients are still experimental and are being studied in clinical trials for safety and effectiveness in chronic wounds infected with Pseudomonas aeruginosa. The sugars are thought to disrupt the bacteria’s ability to stick to the wound and form protective bio‑films, thereby reducing the infection. PB‑TX‑01 is classified as an investigational topical antimicrobial wound care product.

Investigated diseases

Chronic wound colonized with Pseudomonas aeruginosa - A chronic wound is a skin injury that fails to heal within the usual time frame, often lasting longer than three months. When the wound becomes colonized with the bacterium Pseudomonas aeruginosa, the bacteria multiply on the wound surface and in the surrounding tissue. The presence of this organism can cause increased inflammation, a persistent discharge, and a foul odor. Over time, the wound may enlarge or develop a deeper ulcer if the bacterial load is not reduced. The condition can fluctuate, with periods of relative stability followed by episodes of worsening appearance or size. Regular monitoring of the wound’s appearance and bacterial presence is important to understand its course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517491-38-00Protocol codePB-TX-01Estimated enrolment90 patientsSponsorPathoBlock Therapeutics GmbH & Co. KG

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