Chronic Venous InsufficiencyNCT03445091
Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI
A study testing SANKOM Patent Socks in people with Chronic Venous Insufficiency, run by Sankom SA at 2 sites in Ukraine.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- SANKOM Patent Socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUkraine
- Study dates
- 5 Feb 2018to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Kyiv City Clinical Hospital No 6
Kyiv, 03126
Medical Consulting Center of Pechersk District
Kyiv
About this study
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
Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks
Read the 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
- Conditions
- Chronic Venous Insufficiency
- Being tested
- SANKOM Patent Socks
- Keywords
- compression socks, venous insufficiency, compression stockings, compression, compression therapy
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANKOM Patent SocksDevice
Also called gradient compression socks
Using compression socks to ease symptoms of patients with chronic venous insufficiency
| Study group | Role | What they receive |
|---|---|---|
| Patients using investigational product | Experimental | Open-label use of SANKOM Patent Socks Receives: Device: SANKOM Patent Socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Improvement of Quality of Life
Growing of scrore of Quality of life questionnaire in Chronic Lower Limb Venous Insufficiency (CIVIQ-2) is expected
Measured: 4 weeks
Improvement of ultara sound examination measures
Speed of venous blood flow of lower limbs is measured
Measured: 4 weeks
Improvement of subject's self-assessment questionnaire
Subjective assessment of visual analog scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start5 Feb 2018
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sankom SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InterMedService SA, Pharmaxi LLC
- Responsible party
- Sponsor
- Investigators
- Serge M Mazourik, MD, Study chair, Intermedservice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445091
- Sponsor's protocol ID
- Sankom-001
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the data yet.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03445091
- Acronym / sponsor ID
- Sankom-001
- Conditions
- Chronic Venous Insufficiency
- Keywords
- compression socks, venous insufficiency, compression stockings, compression, compression therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sankom SAIndustry (pharma, biotech, devices)
- Collaborators
- InterMedService SA, Pharmaxi LLC
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using investigational product | Experimental | Device: SANKOM Patent SocksOpen-label use of SANKOM Patent Socks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SANKOM Patent SocksAlso: gradient compression socksUsing compression socks to ease symptoms of patients with chronic venous insufficiency | Device | Patients using investigational product |
Primary outcome
Improvement of health status in varicose veins patients
Time frame: 4 weeks
By mean of growing Aberdeen Varicose Veins Questionnaire score (total range 0 - 60). The higher values represent a better outcome.
3 secondary outcomes
Improvement of Quality of Life
Time frame: 4 weeks
Improvement of ultara sound examination measures
Time frame: 4 weeks
Improvement of subject's self-assessment questionnaire
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No. There is no plan to share the data yet.
Related trials for Chronic Venous Insufficiency
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Recruiting
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Pedal Pump Clinical Trial on Edema V2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge M Mazourik, MD study chair
Intermedservice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SANKOM Patent Socks in people with Chronic Venous Insufficiency, run by Sankom SA at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of health status in varicose veins patients (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.