NCT02631512已完成4 期
Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel
Biotec Pharmacon ASA3 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.
研究概览
简要总结
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.
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
- •Type I or II diabetes mellitus.
- •Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
- •Ankle-brachial pressure index above 0.7.
排除标准
- •Ulcers due to non-diabetic etiology.
- •Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status.
- •Ulcers older than 1 year.
- •Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.
研究组 & 干预措施
Woulgan Gel
Other
Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
干预措施: Woulgan Gel (Device)
Intrasite Hydrogel
Other
Primary dressing with Intrasite Hydrogel
干预措施: Intrasite Hydrogel (Device)
结局指标
主要结局
Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.
时间窗: Until 8 weeks from start of treatment
次要结局
- Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events(Until 8 weeks from start of treatment)
- Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS).(Until 8 weeks from start of treatment)
研究者
研究点 (3)
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