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

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

Study Overview

• Status: Recruiting
• Conditions: Ulcer Foot; Ulcer Venous
• Intervention / Treatment: Device: BU002; Device: Polyhexanide 0.1% and betaine 0.1% gel

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María B Olivares, PhD; Phone Number: 3634 562223279634; Email: molivares@udd.cl

Study Locations

• Chile
  • Metropolitana de Santiago
    • Santiago, Metropolitana de Santiago, Chile
      • Recruiting
      • Universidad del Desarrollo
      • Contact: María B Olivares, PhD; Phone Number: 3634 562223279634; Email: molivares@udd.cl
      • Principal Investigator: Daniela Constanza Espinoza, Nurse
      • Sub-Investigator: Isabel Aburto, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BU002; Participants will received BU002 as debridement treatment.	Device: BU002; BU002 is a composition intended for debridement and antibiofilm in wounds.; Other Names: Debricim
Active Comparator: Polihexanide Gel; Participants will received Polihexanide gel as debridement treatment.	Device: Polyhexanide 0.1% and betaine 0.1% gel; Polihexanide combined with betaine is a debridement and antibiofilm comercial product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound area	The total wound area it will be measure by an image software (Ekare Insight)	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound area covered by slough and necrotic tissue	The area will be measured by an image software (Ekare Insight)	Baseline, 4 weeks
Change in wound bacterial load	The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Universidad del Desarrollo
• Collaborators: Fundación Instituto Nacional de Heridas

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Foot Diseases; Skin and Connective Tissue Diseases; Varicose Ulcer; Foot Ulcer
• Other Study ID Numbers: 2024-77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No