Status:
UNKNOWN
Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI
Lead Sponsor:
Sankom SA
Collaborating Sponsors:
InterMedService SA
Pharmaxi LLC
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03445091
Start Date
February 5 2018
End Date
April 1 2018
Last Update
March 2 2018
Active Locations (2)
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1
Kyiv City Clinical Hospital No 6
Kyiv, Ukraine, 03126
2
Medical Consulting Center of Pechersk District
Kyiv, Ukraine