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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：María B Olivares, PhD
- 电话号码：3634 562223279634
- 邮箱：molivares@udd.cl
学习地点
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Metropolitana de Santiago
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Santiago、Metropolitana de Santiago、智利
- 招聘中
- Universidad del Desarrollo
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接触：
- María B Olivares, PhD
- 电话号码：3634 562223279634
- 邮箱：molivares@udd.cl
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首席研究员：
- Daniela Constanza Espinoza, Nurse
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副研究员：
- Isabel Aburto, Nurse
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BU002
Participants will received BU002 as debridement treatment.
|
BU002 is a composition intended for debridement and antibiofilm in wounds.
其他名称：
|
|
有源比较器：Polihexanide Gel
Participants will received Polihexanide gel as debridement treatment.
|
Polihexanide combined with betaine is a debridement and antibiofilm comercial product.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in wound area
大体时间：Baseline, 4 weeks
|
The total wound area it will be measure by an image software (Ekare Insight)
|
Baseline, 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in wound area covered by slough and necrotic tissue
大体时间：Baseline, 4 weeks
|
The area will be measured by an image software (Ekare Insight)
|
Baseline, 4 weeks
|
|
Change in wound bacterial load
大体时间：Baseline, 4 weeks
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The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.
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Baseline, 4 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.