Venous Insufficiency of LegSOCKNLEGLCANCT03743597
SOCKNLEG Compression Stocking Kit: Physical Properties
A study testing SOCKNLEG and Sigvaris COTTON in people with Venous Insufficiency of Leg, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Venous Insufficiency of Leg
- What is being tested?
- SOCKNLEG and Sigvaris COTTON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Nov 2018to 31 Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Informed Consent as documented by signature
- Male or post-menopausal women over the age of 65
- Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
- Indication of a compression therapy by medical compression stocking
Who cannot join
- Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index <0.8 or >1.3
- Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
- Advanced heart insufficiency (NYHA III-IV)
- Contraindications to compression therapy
- Known allergies to any components of the stocking material
- Inability to follow the procedures of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, CH-8091
Juerg Hafner, M.D. Prof., +41 44 255 25 33, juerg.hafner@usz.ch
Juerg Hafner, M.D. Prof.
About this study
Official title: SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.
The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.
In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.
- Conditions
- Venous Insufficiency of Leg
- Being tested
- SOCKNLEG, Sigvaris COTTON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCKNLEGDevice
Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
In each participant all examinations will be performed with both study stockings, one after the other
Sigvaris COTTONDevice
Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
In each participant all examinations will be performed with both study stockings, one after the other
| Study group | Role | What they receive |
|---|---|---|
| SOCKNLEG | Experimental | Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other. Receives: Device: SOCKNLEG; Device: Sigvaris COTTON |
| Sigvaris COTTON | Active comparator | Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other. Receives: Device: SOCKNLEG; Device: Sigvaris COTTON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.
Measured: 1 day, during study visit
Secondary outcomes (4)
Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg
Comparing the SSI at point cC of both stockings with each other and with the standard SSI values at point cB1. The point cC is a new measuring point at the largest circumference of the calf.
Measured: 1 day, during study visit
Dynamic Stiffness Index (DSI) values of both stockings in mmHg
The DSI is a substraction of the Interface Pressures measured at each point (cC and cB1) on the leg during wiping of the foot while wearing a compression stocking. Measuring instruments are again the pressure probes.
Measured: 1 day, during study visit
Venous ejection fraction (VEF) of both stockings in %
Non-invasive measurement of the venous filling volumes of the leg with a strain gauge plethysmography the Angioflow2 (Microlabitalia, Padua, Italy).
Measured: 1 day, during study visit
Interface Pressures at point cB on the leg in mmHg
The point cB is the point of the smallest circumference of the leg and is the standard measuring point for compression strength of a leg compression stocking. Measured with a pressure probe on the leg of the study participant under the compression stocking.
Measured: 1 day, during study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start19 Nov 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Insufficiency of LegStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A computer generated list will allocate each participant to either one of the stockings, the innovative SOCKNLEG, or the standard Sigvaris COTTON stocking. In each participant the examinations will be conducted with both stockings. The allocated group defines with which stocking the examinations will be conducted first.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juerg Hafner, M.D. Prof., Principal investigator, Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743597
- Sponsor's protocol ID
- SL1726
- Acronym
- SOCKNLEGLCA
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2018
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT03743597
- Acronym / sponsor ID
- SOCKNLEGLCA / SL1726
- Conditions
- Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Nov 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.
This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.
The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.
In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A computer generated list will allocate each participant to either one of the stockings, the innovative SOCKNLEG, or the standard Sigvaris COTTON stocking. In each participant the examinations will be conducted with both stockings. The allocated group defines with which stocking the examinations will be conducted first.
| Arm | Type | Receives |
|---|---|---|
| SOCKNLEG | Experimental | Device: SOCKNLEG, Device: Sigvaris COTTONGroup of participant who will conduct the examinations first with the SOCKNLEG compression stockings. All examinations will be conducted in all participants and with both stockings one after the other. |
| Sigvaris COTTON | Active comparator | Device: SOCKNLEG, Device: Sigvaris COTTONGroup of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings. All examinations will be conducted in all participants and with both stockings one after the other. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Informed Consent as documented by signature
- Male or post-menopausal women over the age of 65
- Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
- Indication of a compression therapy by medical compression stocking
Key exclusion criteria (6 listed)
- Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index <0.8 or >1.3
- Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
- Advanced heart insufficiency (NYHA III-IV)
- Contraindications to compression therapy
- Known allergies to any components of the stocking material
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 |
|---|---|---|
| SOCKNLEGInnovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex) In each participant all examinations will be performed with both study stockings, one after the other | Device | SOCKNLEG, Sigvaris COTTON |
| Sigvaris COTTONStandard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton) In each participant all examinations will be performed with both study stockings, one after the other | Device | SOCKNLEG, Sigvaris COTTON |
Primary outcome
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
Time frame: 1 day, during study visit
The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.
4 secondary outcomes
Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg
Time frame: 1 day, during study visit
Dynamic Stiffness Index (DSI) values of both stockings in mmHg
Time frame: 1 day, during study visit
Venous ejection fraction (VEF) of both stockings in %
Time frame: 1 day, during study visit
Interface Pressures at point cB on the leg in mmHg
Time frame: 1 day, during study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Juerg Hafner, M.D. Prof. principal investigator
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCKNLEG and Sigvaris COTTON in people with Venous Insufficiency of Leg, run by University of Zurich at 1 site in Switzerland.
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 6 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Contact Juerg Hafner, M.D. Prof. (+41442552533, juerg.hafner@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg (time frame: 1 day, during study visit). 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 30 Mar 2021.