Chronic Venous Insufficiency Clinical Trial
Official title:
Open Label, Prospective Clinical Trial to Evaluate Impact on Quality of Life in Chronic Venous Insufficiency Patients Using SANKOM® Patent Socks During 4 Weeks
Verified date | February 2018 |
Source | Sankom SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. 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; 2. Subject is male or female, 35-65 years of age; 3. Subject with chronic venous insufficiency CEAP (C1, C2); 4. Subject can speak and understand Ukrainian or Russian language. Exclusion Criteria: 1. Subject participated in any clinical study (drug or device) within 6 months prior to the screening; 2. Subject unable to wear compression stockings; 3. Subject using other compression therapy. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Kyiv City Clinical Hospital No 6 | Kyiv | |
Ukraine | Medical Consulting Center of Pechersk District | Kyiv |
Lead Sponsor | Collaborator |
---|---|
Sankom SA | Intermedservice SA, Pharmaxi LLC |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks | |
Secondary | Improvement of Quality of Life | Growing of scrore of Quality of life questionnaire in Chronic Lower Limb Venous Insufficiency (CIVIQ-2) is expected | 4 weeks | |
Secondary | Improvement of ultara sound examination measures | Speed of venous blood flow of lower limbs is measured | 4 weeks | |
Secondary | Improvement of subject's self-assessment questionnaire | Subjective assessment of visual analog scale | 4 weeks |
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