Chronic wounds heal very slowly or not at all due to a healing disorder, which can be caused by infections, circulatory problems or chronic underlying diseases such as diabetes mellitus. According to health insurance data, around 800,000 people in Germany live with a chronic wound and therefore face substantial and long-term limitations.
Wound treatment is complex, with numerous options available. However, there is a lack of meaningful clinical trials, as well as evidence-based treatment recommendations derived from them. Much of the field of chronic wound treatment remains unexplored, and patient-reported outcomes and side effects are not adequately considered when planning studies.
The Institute for Quality and Efficiency in Health Care (IQWiG) produced a scientific report on clinical trials in wound treatment for the Federal Joint Committee (G-BA), the main decision-making body in the German healthcare system. The report makes specific recommendations for the planning, conduct and assessment of studies on the treatment of chronic wounds, as well as for the assessment of ongoing or completed studies. It therefore sets out the basic requirements for manufacturers with regard to the structured demonstration of benefit.
In its rapid report, IQWiG not only describes wound types and patient-relevant outcomes, but also assesses the methodological instruments (e.g., questionnaires) used to record these outcomes in clinical trials.
"Our rapid report provides clear recommendations on how to generate meaningful evidence in the therapeutic area of wound treatment. High-quality clinical trials are indispensable for the good care of patients with chronic wounds – and they are feasible," says Philip Kranz, Division Head in IQWiG's Drug Assessment Department.
Better evidence for better patient care
German and international guidelines provide recommendations for the treatment of various types of chronic wounds and underlying diseases. The recommendations for wound treatment in the guidelines are mostly based on expert opinion (consensus-based), as data from high-quality studies, such as randomized controlled trials (RCTs), are not available for many procedures and wound types.
In January 2025, IQWiG published a preliminary rapid report on clinical trials in the therapeutic area of wound treatment, with the aim of incorporating the views of medical professionals and other interested parties. The comments and subsequent debate provided valuable insights into wound treatment in clinical practice, enabling an exchange of views on scientific and methodological issues. These findings were then incorporated into the final rapid report. This report will form the basis of future consultations between the G-BA and medical device manufacturers with regard to the demonstration of the benefit of a product.
In future, other wound treatment products (sPzW) that actively promote wound healing can only be prescribed at the expense of statutory health insurance (GKV) once their medical benefit has been assessed by the G-BA at the request of the medical device manufacturer and included in Annex V of the German Medicines Directive. Prior to the benefit assessment, the G-BA advises sPzW manufacturers on the specific content of the documents and studies to be submitted, including patient-relevant outcomes that are relevant for the respective demonstration of benefit.
Good studies with the right outcomes are possible – and necessary
For patients, complete wound closure (i.e., full healing of the wound) is of the utmost importance. Therefore, it is the primary treatment goal and a key patient-relevant outcome in any clinical trial on wound treatment. The importance of quality of life was also highlighted in discussions with affected patients that IQWiG conducted during the preparation of its report. These discussions aimed to gain an understanding of how patients live with chronic wounds, as well as their treatment experiences and wishes. The pain caused by chronic wounds and their consequences, such as restricted mobility, sleep disorders, difficulties with personal hygiene or reduced food intake, can substantially affect quality of life.
However, studies on the treatment of chronic wounds often record many outcomes that are not (clearly) relevant to patients, and partial wound closure is often used as a surrogate parameter for complete wound closure. But as IQWiG has determined, this surrogate has not been validated. Nevertheless, in some situations, partial wound closure can also mean a considerable improvement in patients' life situation – but only if this improvement is noticeable and measurable. A reduction in wound area alone does not constitute a benefit, but it does if it improves health-related quality of life and activities of daily living, for example. Therefore, when linked to at least one directly patient-relevant event, partial wound closure can also represent a patient-relevant outcome in clinical trials.
The treatment of chronic wounds aims to improve symptoms, facilitate activities of daily living, promote social participation and improve health-related quality of life. Clinical trials should therefore always demonstrate the benefit of a treatment in terms of these patient-relevant outcomes. However, such outcomes have rarely been recorded to date.
Procedure of report production
In May 2024, the G-BA commissioned IQWiG to produce a scientific report on clinical trials in the therapeutic area of wound treatment. In January 2025, IQWiG published the preliminary results of the rapid report and invited comments for discussion. Following the commenting procedure, the project team revised the preliminary rapid report and sent it to the G-BA in April 2025. The written comments received and the minutes of the scientific debate were published in a separate document at the same time as the final rapid report (May 2025). An English translation was published in January 2026.
