NCT02091778已完成不适用
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
Molnlycke Health Care AB4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Change in Peri-wound Skin
研究概览
简要总结
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Both gender ≥18 years old.
- •Subjects with type 1 or 2 diabetes mellitus.
- •Texas Grade A1 or 2, C1 or 2
- •Exuding diabetic foot ulcer
- •Ulcer localisation; below the ankle
- •Signed Informed Consent.
排除标准
- •Known allergy/hypersensitivity to the dressing.
- •HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
- •Wound infection requiring systemic treatment
- •Subjects who will have problems following the protocol.
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days.
- •Toe pressure less than 70 mmHg
- •Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)
结局指标
主要结局
Change in Peri-wound Skin
时间窗: 12 weeks
Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
次要结局
未报告次要终点
研究者
研究点 (4)
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