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临床试验/NCT05860439
NCT05860439已完成不适用

Long-term Follow-up of Sclerotherapy of Reticular Veins and Telangiectasias

UPECLIN HC FM Botucatu Unesp1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2017年1月1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
191
试验地点
1
主要终点
Length of Telangiectasias in Centimeters

研究概览

简要总结

A long-term follow-up cohort study of patients that were assigned in two previous studies to compare the clinical results of sclerotherapy of telangiectasias and reticular veins of lower limbs using 0.2% polidocanol diluted in 70% hypertonic glucose (PDHG) vs 75% hypertonic glucose (HG) alone.

All women, previously treated as aforementioned, were invited to be reevaluated regarding late maintenance and pigmentation over two years of follow-up.

No new treatments were applied to the cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients that concluded the participation of 60 days in both primary studies were invited to reevaluate the actual status of treatment (maintenance of treated vessels) and late complications (pigmentation and matting).

排除标准

  • Patients who did not agree to be reassessed;
  • Patients who were not found after all available forms of contact had been tried;
  • Patients who went through any kind of intervention on the area of interest in lower limbs between the end of the intervention and the reevaluation for long-term follow-up.

结局指标

主要结局

Length of Telangiectasias in Centimeters

时间窗: 730 days

Total length of telangiectasias at day 730 for comparison with day 60 and assessment of disease relapse.

次要结局

  • Length of Hyperchromia in Centimeters(730 days)
  • Length of Matting in Centimeters(730 days)

研究者

发起方
UPECLIN HC FM Botucatu Unesp
申办方类型
Other
责任方
Sponsor

研究点 (1)

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