NCT03136822已完成不适用
Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Recovery of the wound 100%
研究概览
简要总结
(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This dressing has been categorised as Class III medical device. This clinical study will be conducted in patients with diabetic foot ulcers.
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
- Single (Outcomes Assessor)
盲法说明
The wound will be assessed by Pathologists who are masked for treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 Patients diagnosed with diabetic foot ulcers
- •Class I and II according to Wagner classification
- •No infections confirmed with culture test
- •No osteomyelitis and gangrene in the foot
- •HbA1c values ≤ % 7.5
- •Not active smoker
- •No planned treatment of hyperbaric oxygen
- •Patients who give consent for the study
排除标准
- •Patients with diabetic foot ulcer of class 3,4 and 5 according to Wagner classification
- •Patients who are pregnant or breast-feeding or female who are in reproductive age applying no preservative method
- •Patients who have mental conditions that lead to difficulties in comprehension
- •Patients who may have compliance issues
- •Patients who have been included to another interventional study with drug or medical device
研究组 & 干预措施
Control
Other
Standard dressing
干预措施: Standard Dressing (Other)
Treatment
Experimental
Standard dressing + Wound dressing (DERMALIX)
干预措施: Standard Dressing (Other)
Treatment
Experimental
Standard dressing + Wound dressing (DERMALIX)
干预措施: DERMALIX (Device)
结局指标
主要结局
Recovery of the wound 100%
时间窗: 1 month
The wound will be completely recovered
次要结局
- Recovery of the wound 80%(1 month)
研究者
研究点 (2)
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