RecruitingNot ApplicableNCT07607106

Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers

New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers


Sponsor

Universidad del Desarrollo

Enrollment

80 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BU002 and a medical device called Polyhexanide 0.1% and betaine 0.1% gel for people with ulcer foot and ulcer venous. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBU002

BU002 is a composition intended for debridement and antibiofilm in wounds.

DEVICEPolyhexanide 0.1% and betaine 0.1% gel

Polihexanide combined with betaine is a debridement and antibiofilm comercial product.


Locations(1)

Universidad del Desarrollo

Santiago, Metropolitana de Santiago, Chile

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NCT07607106


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