Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI

NCT03445091 | Unknown

• 1 other identifier: Sankom-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Venous Insufficiency

Keywords

compression socks; venous insufficiency; compression stockings; compression; compression therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement of Quality of Life

  4 weeks

• Improvement of ultara sound examination measures

  4 weeks

• Improvement of subject's self-assessment questionnaire

  4 weeks

Study Arms (1)

Patients using investigational product

EXPERIMENTAL

Open-label use of SANKOM Patent Socks

Device: SANKOM Patent Socks

Interventions

SANKOM Patent Socks DEVICE

Using compression socks to ease symptoms of patients with chronic venous insufficiency

Also known as: gradient compression socks

Patients using investigational product

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sankom SA: lead
• InterMedService SA: collaborator
• Pharmaxi LLC: collaborator

Study Sites (2)

Kyiv City Clinical Hospital No 6

Kyiv, 03126, Ukraine

Location

Medical Consulting Center of Pechersk District

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Serge M Mazourik, MD

  Intermedservice

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 26, 2018
• Study Start: February 5, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)