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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство BU002
  BU002 is a composition intended for debridement and antibiofilm in wounds.
• Устройство Polyhexanide 0.1% and betaine 0.1% gel
  Polihexanide combined with betaine is a debridement and antibiofilm comercial product.

Первичные конечные точки

• Change in wound area [Срок оценки: Baseline, 4 weeks]

Вторичные конечные точки (2)

• Change in wound area covered by slough and necrotic tissue [Срок оценки: Baseline, 4 weeks]
• Change in wound bacterial load [Срок оценки: Baseline, 4 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Universidad del Desarrollo — Santiago

Идентификаторы

NCT: NCT07607106 · 2024-77

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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