A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 56
- 主要终点
- Measure the volume change of skin lesions by ultrasound
研究概览
简要总结
56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast. After a period of time ,we can determine the efficacy of the drug by detecting the the thickness of skin before and after treatment.
详细描述
56 patients with Scleredema Diabeticorum will be selected. After the signing of the informed consent ,they will be collected the initial lesions photos,the thickness of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.During tranilast (0.1g each time, three times a day,6 months) treatment, patients need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness.With 3 month as a time point, they were observed for two points.After the experiment, the experimental data will be arranged and the data of the thickness change of skin lesions will be statistically processed (t test) to determine whether it is meaningful.
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
- •(1)Clinical and histopathological examination has been proved to be scleredema diabeticorum; (2)Ultrasound and magnetic resonance detection found that the thickest skin of the back was more than 5mm.
排除标准
- •(1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)Poor blood sugar control; (3)with mental disease.
研究组 & 干预措施
Tranilast
干预措施: Tranilast (Drug)
结局指标
主要结局
Measure the volume change of skin lesions by ultrasound
时间窗: This experiment will last for 6 months
During tranilast (0.1g each time, three times a day, 6 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective
次要结局
未报告次要终点