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临床试验/NCT02050061
NCT02050061已完成不适用

Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life

Qassim University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI

研究概览

简要总结

Chronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs leading to significant impact on the quality of life. There is no study, to our knowledge, has attempted to evaluate the impact of compression stockings on all patients with CVI. Our aim is to estimate the prevalence of CVI in Qassim Region and to test the effectiveness of compression stockings.

详细描述

Study design: Two phases Phase 1: Cross Sectional descriptive study Phase 2: Prospective Interventional study

Study site and population:

The study was conducted within multiple Primary Health Care (PHC) centers in Buraidah and Unaizah, the largest two cities in Qassim region, estimated population 800,000. We recruited all consecutive patients visited the primary health care center for various reasons until we have reached 100 participants clinically diagnosed with CVI. Informed consent was obtained from all screened participants.

Exclusion criteria: Pregnant women and those patients who refused or unable to obtain an informed consent.

Phase 1: We conducted a cross sectional study among patients attending PHC Centers of Qassim region. The duration of study was six months, from October 2011 to March 2012. Patients are consecutively interviewed and a dedicated questionnaire designed for this study applied to them. They were assessed using the most recent scale for CVI assessment, which is the clinical severity, etiology or cause, anatomy, pathophysiology (CEAP) scale. The study continued until we have achieved 100 patients with clinical diagnosis of CVI as per CEAP classification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants clinically diagnosed with CVI

排除标准

  • Pregnant women and those patients who refused or unable to obtain an informed consent.

结局指标

主要结局

CEAP stands for clinical, etiologic, anatomical, and pathophysiological findings scale which is usually used for diagnosis and classification CVI

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulrahman Al-Mohaimeed

Doctor

Qassim University

研究点 (2)

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