Open Label, Prospective Clinical Trial to Evaluate Impact on Quality of Life in Chronic Venous Insufficiency Patients Using SANKOM® Patent Socks During 4 Weeks
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Improvement of health status in varicose veins patients
研究概览
简要总结
Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks
详细描述
Despite the application of compression stockings looks simple, it must be remembered that inappropriately worn stockings have the potential to cause certain problems. Unevenly distributed and excess pressure may break the skin, especially in older, malnourished patients and those with thin, brittle skin.
Although an extreme case, it highlights the importance of careful assessment, application, and monitoring of compression stockings.
Typically, the stockings are safe and wearing them results in few or no complications, provided they're worn smoothly against the leg, without any folds. But some groups of people should avoid them, including those with peripheral neuropathy or any other condition that impacts skin sensation; a history of a peripheral arterial bypass grafting; peripheral artery disease; skin infection; dermatitis with oozing or fragile skin; massive leg swelling; or pulmonary edema from congestive heart failure. Each of these conditions presents a different series of risks. For example, for people with peripheral artery disease, stockings can worsen oxygen delivery in arteries with impaired blood flow. People who have sensory problems, such as those with peripheral neuropathy, may not feel when a compression stocking is too tight, which could impede circulation. And certain skin conditions or infections may worsen with a compression stocking covering and pressing on the area.
In general, if subject has any medical condition, he/she should talk with health care professional before using compression stockings to see if they are good candidate for them.
Since probability of side/adverse effects from IP use is considered as very low vs of high probability of expected positive effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent before any procedure;
- •Subject is male or female, 35-65 years of age;
- •Subject with chronic venous insufficiency CEAP (C1, C2);
- •Subject can speak and understand Ukrainian or Russian language.
排除标准
- •Subject participated in any clinical study (drug or device) within 6 months prior to the screening;
- •Subject unable to wear compression stockings;
- •Subject using other compression therapy.
结局指标
主要结局
Improvement of health status in varicose veins patients
时间窗: 4 weeks
By mean of growing Aberdeen Varicose Veins Questionnaire score (total range 0 - 60). The higher values represent a better outcome.
次要结局
- Improvement of Quality of Life(4 weeks)
- Improvement of ultara sound examination measures(4 weeks)
- Improvement of subject's self-assessment questionnaire(4 weeks)
