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

NCT07607106 | Recruiting

• 1 other identifier: 2024-77
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcer Venous; Ulcer Foot

Outcome Measures

Primary Outcomes (1)

• Change in wound area

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

  Baseline, 4 weeks

Secondary Outcomes (2)

• Change in wound area covered by slough and necrotic tissue

  Baseline, 4 weeks

• Change in wound bacterial load

  Baseline, 4 weeks

Study Arms (2)

BU002

EXPERIMENTAL

Participants will received BU002 as debridement treatment.

Device: BU002

Polihexanide Gel

ACTIVE COMPARATOR

Participants will received Polihexanide gel as debridement treatment.

Device: Polyhexanide 0.1% and betaine 0.1% gel

Interventions

BU002 DEVICE

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

Also known as: Debricim

BU002

Polyhexanide 0.1% and betaine 0.1% gel DEVICE

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

Polihexanide Gel

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Fundación Instituto Nacional de Heridas: collaborator

Study Sites (1)

Universidad del Desarrollo

Santiago, Metropolitana de Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases

Central Study Contacts

María B Olivares, PhD

CONTACT

562223279634; molivares@udd.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Products are identified as A o B
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

CL (1)