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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine, 03126
    • Kyiv City Clinical Hospital No 6
  • Kyiv, Ukraine
    • Medical Consulting Center of Pechersk District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients using investigational product; Open-label use of SANKOM Patent Socks	Device: SANKOM Patent Socks; Using compression socks to ease symptoms of patients with chronic venous insufficiency; Other Names: gradient compression socks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Improvement of ultara sound examination measures	Speed of venous blood flow of lower limbs is measured	4 weeks
Improvement of subject's self-assessment questionnaire	Subjective assessment of visual analog scale	4 weeks

Collaborators and Investigators

• Sponsor: Sankom SA
• Collaborators: InterMedService SA; Pharmaxi LLC
• Investigators: Study Chair: Serge M Mazourik, MD, Intermedservice

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: compression therapy; venous insufficiency; compression socks; compression stockings; compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: Sankom-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share the data yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No