ISRCTN51795022已完成不适用
Open-label pilot study on the effect of Bosentan on trophic skin lesions in the diabetic fOOT Syndrome
niversity Hospital Zürich (Switzerland)0 个研究点目标入组 20 人开始时间: 2012年2月20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
- 20
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
- •1. Provided written informed consent
- •2. Male and female patients aged > 18 years
- •3. With diabetic foot syndrome (irrespective of catheter technical or surgical revascularisation plans and irrespective of the presence of any infection)
排除标准
- •1. Trophic skin lesions due to other diseases than diabetes
- •2. Planned amputation within the following 4 months
- •3. Revascularisation within 4 weeks prior to inclusion
- •4. Systolic BP < 85 mm Hg
- •5. Hb <75% of the lower limit of normal
- •6. Severe malabsorption or any severe organ failure or any life-threatening state
- •7. Contraindications to the use of bosentan
- •8. Previous treatment with bosentan
- •9. Treatment with botulinus toxin, prostanoids, sildenafil or any other experimental treatment
- •10. Body weight< 40 kg
- •11. Patients unable to provide informed consent and comply with the protocol
研究者
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