A new treatment option for patients with infected chronic wounds

Your participation counts!

Do you have a poorly healing wound infected with Pseudomonas aeruginosa (one of the most common hospital pathogens)? Then this clinical trial could be of interest to you and offer you treatment with a new therapeutic approach.

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At a glance:

  • The investigational product has a new mechanism of action.
  • During the clinical trial, you will come in for five visits at the Asklepios Klinik in Hamburg Wandsbek. In addition, you will receive daily wound care at your home for two weeks, provided by mobile wound care specialists.
  • Participation means no costs for you whatsoever – travel expenses will be reimbursed upon presentation of receipts.
  • You are insured for the entire duration of the trial.
  • The clinical trial has been approved by the responsible regulatory authority and received a positive opinion from the ethics committee.
  • Medical oversight is provided by Prof. Dr. med. Christian-Alexander Behrendt, Head of Vascular Surgery, Asklepios Wandsbek.

Prof. Dr. med. Christian-Alexander Behrendt

Head of Vascular Surgery, Asklepios Klinik Wandsbek, Principal Investigator

Dear patient,

if you suffer from a wound that won't heal, you know how much this condition can limit your everyday life. Despite careful wound care, healing is often slow – especially when the wound is infected with bacteria that can delay wound healing.

Our clinical trial at the Asklepios Klinik in Hamburg Wandsbek aims to explore new ways to improve the treatment of chronic wounds infected with the germ “Pseudomonas aeruginosa”, and, if successful, to give you a better quality of life.

Participation is entirely voluntary. Before you decide, you will receive all the important information in an easy-to-understand form, and our study team will take the time to answer your questions. We will only begin any trial-related procedures once you have given your written consent after a thorough explanation.

All treatments are carried out exclusively by trained medical staff. There are no costs for you – travel expenses will be reimbursed.

If you are interested or would like to learn more, please feel free to contact our study team – we are here for you.

Prof. Dr. med. Christian-Alexander Behrendt
Head of Vascular Surgery, Asklepios Klinik Wandsbek, Principal Investigator

Who can take part in the trial?

The trial is aimed at adults who have a chronic wound colonized with Pseudomonas aeruginosa.

You may be eligible to take part if:

  • You are at least 18 years old.
  • You have been diagnosed with a chronic wound colonized with Pseudomonas aeruginosa.
  • You are available every day for dressing changes (at your home) during the 14-day treatment period.
  • You are willing to come to the clinic for two screening and three follow-up visits.

Participation in the trial is not possible if:

  • You are pregnant or breastfeeding.
  • Your wound is larger than 50 cm2.
  • A surgical procedure to improve blood circulation is planned for you during the trial.
  • You have galactosemia or another disorder of D-galactose metabolism.

The study team will clarify any further participation requirements directly with you.

How does the trial work?

We are testing a new medicine called PB-TX-01, which is designed to prevent Pseudomonas aeruginosa bacteria from attaching to human cells and thereby improve your wound healing. The aim of the trial is to gain insights into the efficacy and tolerability of PB-TX-01 by comparing it with standard therapy.

If you take part in the trial, it will last two weeks for you, with one follow-up visit after one month and another after three months. During this time, you will come to the clinic for examinations five times in total. In addition, a qualified wound care specialist will treat you at home once a day over a period of 13 days. Each treatment takes no longer than one hour and includes cleaning the wound, changing the dressing, and the necessary documentation. You can continue taking your regular medication as usual (except antibiotics in tablet form). At the beginning and at the end of the trial, a blood sample will be taken for safety reasons. No further burdensome examinations are planned.

The trial is divided into two groups of around 45 patients each:

  • The first group is treated once daily with the investigational product.
  • The second group is treated once daily with the approved medicine Serasept, which is used as part of standard therapy.

Assignment to a group is random, through a process called randomization. The following graphic illustrates the course of the trial.

What can you expect during the trial?

5

Visits at Asklepios Klinik Wandsbek

13

Days of mobile treatment at your home

2

Follow-up visits after one and after three months

5

Blood draws

Trial site

The clinical trial is being conducted at the Asklepios Klinik in Hamburg Wandsbek. Patients with chronic wounds are treated here, in particular those with circulatory disorders such as diabetic foot syndrome or leg ulcers. The Department of Vascular Surgery has extensive experience in caring for wounds that are difficult to heal. Under the leadership of Prof. Dr. med. Christian-Alexander Behrendt, a specialized team is responsible for treatment and care within the clinical trial.

Alphonsstraße 14, 22043 Hamburg
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Frequently Asked Questions (FAQ)

About the investigational product

The active substances in PB-TX-01 are two naturally occurring compounds that, in small amounts, are even produced by the human body itself – and are therefore not foreign to it.

PB-TX-01 has a new mechanism of action. Pseudomonas aeruginosa bacteria produce two bridging molecules that they use to attach to human cells. This attachment is essential for the bacteria to multiply. The active substances in PB-TX-01 block these bridging molecules, preventing the bacteria from attaching to human cells. In this way, the bacterium is disarmed and is no longer harmful to the human body. The natural substances in PB-TX-01 also draw moisture out of the wound. A moist environment is essential for the survival of many types of bacteria. Through this additional drying effect, other bacteria are also naturally removed from the wound.

The same active substances used in PB-TX-01 have already been used in humans in a number of cases. Positive effects were observed and no side effects were reported. In the current clinical trial, however, the investigational product is being administered for the first time in this specific formulation and dosage.

The investigational product is a white powder that is applied superficially to the affected wound by trained staff. Administration takes place on day 1 at the clinic and on the following 13 days at your home. A professional wound care specialist will change your dressing, clean the wound, apply the investigational product to the wound, and then apply a new dressing.

To date, no adverse effects or complaints have occurred under treatment with PB-TX-01. As with any medicine, however, new, previously unknown side effects may occur with the use of PB-TX-01, such as skin irritation like itching or inflammation. The first treatment therefore takes place at the clinic, so that any reactions can be treated by a doctor immediately.

That depends on the type of medicine. If you are currently taking antibiotics, this could lead to exclusion from participation in the trial.

In addition, you cannot take part in the clinical trial if you are currently taking part in another trial.

About the comparator medicine

Serasept is an antiseptic solution for wound care that is used to clean wounds and helps reduce germs such as bacteria and fungi. Its active substance is polyhexanide. Serasept is an approved medicine and is used as the standard treatment for infected wounds.

Overall, Serasept is considered well tolerated. As with all medicines, however, side effects can also occur with Serasept. These are well known and listed in the package leaflet. Your trial physician will inform you accordingly.

About the trial and how it works

All newly developed medicines must first be tested in clinical trials before they can be approved for general use. These trials closely examine both the efficacy and the tolerability of the medicine. Clear legal requirements apply, and trial participants receive intensive medical care. For patients, taking part in a clinical trial can offer the chance to gain access to a new active substance for treating their condition even before it receives official approval.

The aim of the trial is to investigate the tolerability and efficacy of the investigational product PB-TX-01 compared with the comparator product for the treatment of chronic wounds infected with Pseudomonas aeruginosa, and thereby improve treatment options for chronic wounds in the long term.

If you receive the investigational or the comparator product, your condition could improve, since both have an antibacterial effect. Infections with Pseudomonas aeruginosa can significantly delay the healing of chronic wounds. The investigational product PB-TX-01 works by breaking up the bacteria's protective biofilm while at the same time removing the moisture the bacteria need to survive. This allows Pseudomonas aeruginosa and other bacteria to be fought more effectively.

Since the efficacy of PB-TX-01 has not yet been conclusively proven, it is possible that you personally will not benefit from it. However, you will benefit from intensive care: regular wound cleaning, daily dressing changes, and continuous antibacterial treatment can support healing. Regardless of any personal benefit, your participation helps to improve the treatment of chronic wounds in the future.

The trial is conducted at the Asklepios Klinik in Hamburg Wandsbek. As part of the trial, you will come to the clinic five times in total and will also be treated at home by mobile wound care specialists.

For you, the trial consists of a total of five visits to the Asklepios Klinik in Wandsbek, as well as a two-week treatment phase with daily treatment of your wound at your home. The final follow-up visit takes place around 3 months after the first treatment.

No. If you take part, you will receive either PB-TX-01 or Serasept. This is decided by a random process, comparable to a coin toss. The probability of receiving PB-TX-01 is 50%.

The trial is sponsored and funded by PathoBlock Therapeutics GmbH & Co. KG, Leipziger Straße 51, 10117 Berlin. PathoBlock relies on a novel antimicrobial approach: instead of killing bacteria directly, they are rendered harmless by blocking specific bridging molecules. This is intended to create an alternative to conventional antibiotics that does not promote the development of resistance.

Yes. You can end your participation in the trial at any time and without giving reasons. This will not result in any disadvantages for your further medical treatment.

About the data collected

During the clinical trial, medical findings (health data, pre-existing conditions, etc.) as well as personal information (such as age, sex, ethnic origin, etc.) are collected from you and recorded and/or stored electronically in your trial-related documents at the clinical trial site. The data relevant to the clinical trial is additionally stored in pseudonymized (encrypted) form in a system provided by the sponsor and transmitted to the sponsor via this system. Pseudonymized means that no information that could directly identify you (e.g. name, contact details, date of birth, etc.) is used, but only a numeric code. The storage, transmission, security, and analysis of your data are always carried out in such a way that your data is protected against unauthorized access at all times.

Contact

If you are interested in taking part in the trial or need further information, please contact:

Asklepios Klinik Wandsbek

Department of General and Endovascular Vascular Surgery

Alphonsstraße 14
22043 Hamburg, Germany

+49 40 181883-1771 (Mon–Fri, 9am–4pm)

studie@pathoblock.com

Are you a wound care expert? Join the trial!

For mobile wound care as part of this clinical trial, we are looking for additional wound care experts (m/f/d) to work in the north-east of Hamburg.

More information