A Multi-Centre, Randomized, 2-arm, Open-labelled, Controlled PMCF Study to Evaluate the Safety and Performance of ChitoCare Medical Wound Healing Gel in Healing of Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 18
- 主要终点
- Time to complete healing
研究概览
简要总结
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.
详细描述
The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be given
- •Patient ≥ 18 years old
- •Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:
- •Size of the wound ≥ 0.5 cm2
- •Wound is not infected at the time of randomization
- •Wound is present for at least 4 weeks
- •Able to understand and comply with the requirements of the study
排除标准
- •Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb<100 g/L), neoplasia)
- •Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
- •Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator
- •Patients diagnosed with autoimmune connective tissue diseases
- •Previous treatment under this clinical protocol
- •Participation in another clinical trial
- •Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
- •Allergy to shellfish (for active study group)
- •Medical condition likely to require systemic corticosteroids during the study period
- •Pregnant and lactating women
结局指标
主要结局
Time to complete healing
时间窗: up to 18 months
Hazard ratio for time to complete healing (active group vs. control group).
次要结局
- Complete healing rate(4 weeks, 12 weeks)
- Reduction of wound size(4 weeks, 12 weeks)
- Time to 75% and 50% healing(up to 18 months)
- 75% and 50% healing rate(4 weeks, 12 weeks)
- Secondary infections(up to 18 months)
- Incidence of adverse events (Safety of use)(up to 18 months)