Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI
Primary Purpose
Chronic Venous Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
SANKOM Patent Socks
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Venous Insufficiency focused on measuring compression socks, venous insufficiency, compression stockings, compression, compression therapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Kyiv City Clinical Hospital No 6
- Medical Consulting Center of Pechersk District
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients using investigational product
Arm Description
Open-label use of SANKOM Patent Socks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Improvement of Quality of Life
Growing of scrore of Quality of life questionnaire in Chronic Lower Limb Venous Insufficiency (CIVIQ-2) is expected
Improvement of ultara sound examination measures
Speed of venous blood flow of lower limbs is measured
Improvement of subject's self-assessment questionnaire
Subjective assessment of visual analog scale
Full Information
NCT ID
NCT03445091
First Posted
February 14, 2018
Last Updated
February 28, 2018
Sponsor
Sankom SA
Collaborators
InterMedService SA, Pharmaxi LLC
1. Study Identification
Unique Protocol Identification Number
NCT03445091
Brief Title
Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sankom SA
Collaborators
InterMedService SA, Pharmaxi LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
compression socks, venous insufficiency, compression stockings, compression, compression therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients using investigational product
Arm Type
Experimental
Arm Description
Open-label use of SANKOM Patent Socks
Intervention Type
Device
Intervention Name(s)
SANKOM Patent Socks
Other Intervention Name(s)
gradient compression socks
Intervention Description
Using compression socks to ease symptoms of patients with chronic venous insufficiency
Primary Outcome Measure Information:
Title
Improvement of health status in varicose veins patients
Description
By mean of growing Aberdeen Varicose Veins Questionnaire score (total range 0 - 60). The higher values represent a better outcome.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement of Quality of Life
Description
Growing of scrore of Quality of life questionnaire in Chronic Lower Limb Venous Insufficiency (CIVIQ-2) is expected
Time Frame
4 weeks
Title
Improvement of ultara sound examination measures
Description
Speed of venous blood flow of lower limbs is measured
Time Frame
4 weeks
Title
Improvement of subject's self-assessment questionnaire
Description
Subjective assessment of visual analog scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge M Mazourik, MD
Organizational Affiliation
Intermedservice
Official's Role
Study Chair
Facility Information:
Facility Name
Kyiv City Clinical Hospital No 6
City
Kyiv
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Medical Consulting Center of Pechersk District
City
Kyiv
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the data yet.
Learn more about this trial
Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI
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