ISRCTN16663820进行中（未招募）Unknown
Demonstration of the physical wound cleansing performance of Actimaris sensitive solution and gel as well as Microdacyn solution and gel based on the reduction of wound debris
ActiMaris AG Switzerland0 个研究点目标入组 100 人开始时间: 2024年1月31日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients with chronic wounds:
- •1. Ulcus cruris venosum
- •2. Ulcus cruris mixtum: KADI (ankle-brachial index = 0.7)
- •3. Diabetic neuropathic foot ulcer (Wagner-Armstrong 1A and 3A) if they are weakly to heavily exuding and superficial to max. 2 cm deep
- •4. Wound surface area min. 1 cm²
- •5. Wound age at least 8 weeks
- •6. Causal cause diagnosed and (re-)treated
- •7. Wounds show at least a slight odour in the clinical assessment (slight odour according to the Odour Assessment Scoring Tool or odour 1 according to the AVLON scale)
- •8. At least 50 % of the wound surface shows yellowish (fibrinoid) adherent debris at the time of study inclusion
排除标准
- •1. Pure PAOD-related ulceration
- •2. Purely lymphological entities
- •3. Acute wounds
- •4. Chronic wounds with signs of infection
- •5. Age <18, > 85 years
- •6. Allergy to one or more of the substances used
- •7. Pregnancy and breastfeeding
- •8. Inability to adequately participate in the study
研究者
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