About this trial
This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel.
About 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results.
The study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and treat the wound. The study team will:
* Measure the size of the wound * Take small samples from the wound to check for bacteria * Ask questions about pain and general health * Check blood flow in the legs * Perform blood tests at the beginning A specialist doctor will examine the wound at the start and at the end of the study to see how it has improved.
Overall, this study aims to find out if the new treatment can help wounds heal better and more quickly than current standard care.
Taking part in the study is completely voluntary. Participants can leave the study at any time without affecting their usual medical care. All personal and medical information will be kept confidential.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
BU002
DeviceBU002 is a composition intended for debridement and antibiofilm in wounds.
Polyhexanide 0.1% and betaine 0.1% gel
DevicePolihexanide combined with betaine is a debridement and antibiofilm comercial product.
Treatment groups
Trial outcomes
Primary outcomes
Change in wound area
The total wound area it will be measure by an image software (Ekare Insight)
Secondary outcomes
Change in wound area covered by slough and necrotic tissue
The area will be measured by an image software (Ekare Insight)
Change in wound bacterial load
The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad del Desarrollo
Lead sponsor
Fundación Instituto Nacional de Heridas
Collaborator