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NCT Number: NCT07607106

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

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad del Desarrollo

Santiago, Metropolitana de Santiago, Chile

Location status: Recruiting

Location contact

Daniela Constanza Espinoza, Nurse

PRINCIPAL_INVESTIGATOR

Isabel Aburto, Nurse

SUB_INVESTIGATOR

María B Olivares, PhD

CONTACT

[email protected]

562223279634 ext. 3634

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization.

A duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years.

Age over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age.

An ankle-brachial index between 0.6 and 1.3.

Exclusion criteria

Morbid obesity (BMI > 35)

History of cancer treatment in the last year

Uncontrolled diabetes (Glycated Hemoglobin above 10 mg/dL)

Uncontrolled hypertension (blood pressure readings greater than 140/90 mmHg)

Patients with a known allergy to the components of the products under study.

Patients with signs of infection or undergoing antibiotic therapy.

Treatment and study plan

BU002

Device

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

Other names: Debricim

Polyhexanide 0.1% and betaine 0.1% gel

Device

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

Primary outcomes

  1. Change in wound area

    Time frame: Baseline, 4 weeks

    The total wound area it will be measure by an image software (Ekare Insight)

Secondary outcomes

  1. Change in wound area covered by slough and necrotic tissue

    Time frame: Baseline, 4 weeks

    The area will be measured by an image software (Ekare Insight)

  2. Change in wound bacterial load

    Time frame: Baseline, 4 weeks

    The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.

Study contacts

Contact information is provided by the study sponsor or research team.

María B Olivares, PhD

CONTACT

[email protected]

562223279634 ext. 3634

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Collaborators

  • Fundación Instituto Nacional de Heridas

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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