An interventional study of SANKOM Patent Socks in Chronic Venous Insufficiency, sponsored by Sankom SA. Status unknown at 2 sites in Ukraine. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Sankom SA · Not applicable, Interventional, and Supportive care
Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks
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.
Study Purpose and Design Multi-center, observational open label study aimed to evaluate an impact on quality of life in Chronic Venous Insufficiency patients using SANKOM® Patent Socks during 4 weeks
This study will involve a maximum of 30 subjects. Subjects will be followed through outpatient's observation.
Primary Objective
Improvement of QoL by scores of:
Secondary Objectives
Secondary Endpoints are:
Exclusion Criteria:
Open-label use of SANKOM Patent Socks
Device: SANKOM Patent Socks
Using compression socks to ease symptoms of patients with chronic venous insufficiency
Also known as: gradient compression socks
Improvement of health status in varicose veins patients
By mean of growing Aberdeen Varicose Veins Questionnaire score (total range 0 - 60). The higher values represent a better outcome.
Time frame: 4 weeks
Improvement of Quality of Life
Growing of scrore of Quality of life questionnaire in Chronic Lower Limb Venous Insufficiency (CIVIQ-2) is expected
Time frame: 4 weeks
Improvement of ultara sound examination measures
Speed of venous blood flow of lower limbs is measured
Time frame: 4 weeks
Improvement of subject's self-assessment questionnaire
Subjective assessment of visual analog scale
Time frame: 4 weeks
Plan to share: No — There is no plan to share the data yet.
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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