Venous Insufficiency of LegSOCKNLEGZHNCT03429959
SOCKNLEG Compression Stocking Kit : User Friendliness
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
The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. 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
- 47 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2018to 30 Jun 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 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 postmenopausal female patient, aged over 65 years of age
- Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)
Who cannot join
- Venous leg ulcer with a surface >5cm2
- Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index <0.8 or >1.3)
- Difference in brachial blood pressure >20mmHg in both arms
- Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test
- Inability to reach the forefoot with their hands
- Inability to follow the procedures of the study
- Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, CH-8091
About this study
Official title: SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years.
After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group.
All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.
- 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
Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking
SIGVARIS CottonDevice
SIGVARIS Cotton
| Study group | Role | What they receive |
|---|---|---|
| SOCKNLEG | Experimental | Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg Receives: Device: SOCKNLEG |
| SIGVARIS Cotton | Active comparator | Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg Receives: Device: SIGVARIS Cotton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who completely don the two investigated leg compression devices
Measured: through study completion, within 7 months
Secondary outcomes (4)
Number of patients who completely doff the two investigated leg compression devices
Measured: through study completion, within 7 months
Patient evaluation of user friendliness
Evaluation of user friendliness using the ICC compression questionnaire
Measured: 3 days
Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
Assessment by measuring leg volume at the morning visit 3, compared to leg volume at the evening visit 4 and by comparing the leg volumes of visit 4 (compression) to visit 2 (no compression for 1 day)
Measured: 3 days
Time needed to don and doff the two investigated leg compression
Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start10 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juerg Hafner, Prof., Principal investigator, Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429959
- Sponsor's protocol ID
- SL1725
- Acronym
- SOCKNLEGZH
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2017
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT03429959
- Acronym / sponsor ID
- SOCKNLEGZH / SL1725
- Conditions
- Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 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.
The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years.
After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group.
All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOCKNLEG | Experimental | Device: SOCKNLEGDonning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg |
| SIGVARIS Cotton | Active comparator | Device: SIGVARIS CottonDonning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature
- Male or postmenopausal female patient, aged over 65 years of age
- Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)
Key exclusion criteria (7 listed)
- Venous leg ulcer with a surface >5cm2
- Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index <0.8 or >1.3)
- Difference in brachial blood pressure >20mmHg in both arms
- Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test
- Inability to reach the forefoot with their hands
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 |
|---|---|---|
| SOCKNLEGDonning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking | Device | SOCKNLEG |
| SIGVARIS CottonSIGVARIS Cotton | Device | SIGVARIS Cotton |
Primary outcome
Number of patients who completely don the two investigated leg compression devices
Time frame: through study completion, within 7 months
4 secondary outcomes
Number of patients who completely doff the two investigated leg compression devices
Time frame: through study completion, within 7 months
Patient evaluation of user friendliness
Time frame: 3 days
Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
Time frame: 3 days
Time needed to don and doff the two investigated leg compression
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- 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, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients who completely don the two investigated leg compression devices (time frame: through study completion, within 7 months). 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 27 Jun 2019.