NCT06667752进行中（未招募）不适用
A Randomized, Double Blind, Active Controlled, Parallel Group Clinical Trial to Assess the Safety and Efficacy of Nanordica Antibacterial Wound Dressing in Patients With DFUs
Nanordica Medical OU23 个研究点 分布在 2 个国家目标入组 136 人开始时间: 2024年10月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
- 试验地点
- 23
- 主要终点
- CWC at 12 weeks
研究概览
简要总结
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers. At least 136 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.
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
- Double (Participant, Outcomes Assessor)
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
- •Voluntary, written informed consent obtained prior to any study related activities.
- •Males and females aged ≥18 years.
- •DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm.
- •IWGDF/IDSA Wound infection grades 1 (absent) or
- •Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.
- •Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg.
排除标准
- •Ssystemic or topical antibiotic therapy within 7 days before the enrolment.
- •Any wound with known associated osteomyelitis or positive probe-to-bone test.
- •Previous randomization in this clinical trial.
- •Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study.
- •Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks.
- •Patients suffering cardiac disorders grade NYHA IV.
- •Patients suffering hepatic disorders grade Child-Pugh C.
- •Stage 4 cancer.
- •Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.
研究组 & 干预措施
Advanced Antibacterial Wound Dressing
Experimental
干预措施: Advanced Antibacterial Wound Dressing (Device)
Aquacel Ag+ Extra
Active Comparator
干预措施: Aquacel Ag+ Extra (Device)
结局指标
主要结局
CWC at 12 weeks
时间窗: 12 weeks
complete wound closure (CWC) at 12 weeks
Composite Wound Healing Response at 12 weeks
时间窗: 12 weeks
Composite Wound Healing Response (CWHR) defined as either a wound area reduction (WAR) of more than 50% at 4 weeks relative to baseline (WAR50/4) and/or complete wound closure (CWC) at 12 weeks (CWC/12)
次要结局
- CWC at 4 weeks(4 weeks)
- Time to heal(Up to 12 weeks)
- Adverse events(12 weeks)
- Wound area reduction at 4 weeks(4 weeks)
研究者
研究点 (23)
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