NCT07607106 Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers
| NCT ID | NCT07607106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad del Desarrollo |
| Condition | Ulcer Venous |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07607106 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Ulcer Venous. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607106 currently recruiting?
Yes, NCT07607106 is actively recruiting participants. Contact the research team at molivares@udd.cl for enrollment information.
Where is the NCT07607106 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07607106 clinical trial?
NCT07607106 is sponsored by Universidad del Desarrollo. The trial plans to enroll 80 participants.