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

NCT07607106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-26

No results posted yet for this study

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

Interventions

DEVICE

BU002

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

DEVICE

Polyhexanide 0.1% and betaine 0.1% gel

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

Sponsors & Collaborators

  • Fundación Instituto Nacional de Heridas

    collaborator UNKNOWN

  • Universidad del Desarrollo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-10-01
Completion
2026-12-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607106 on ClinicalTrials.gov