NCT03445091

Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI

Open Label, Prospective Clinical Trial to Evaluate Impact on Quality of Life in Chronic Venous Insufficiency Patients Using SANKOM® Patent Socks During 4 Weeks

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sankom SA · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks

Detailed description

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: * Aberdeen Varicose Veins Questionnaire (AVVQ) * CIVIQ-2 Venous Quality of Life Questionnaire Secondary Objectives Secondary Endpoints are: * Improvement of US-examination picture * Improvement of QoL by Subject's questionnaire

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	SANKOM Patent Socks	Using compression socks to ease symptoms of patients with chronic venous insufficiency

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2018-02-26
• Last updated: 2018-03-02

Locations

2 sites across 1 country: Ukraine