Chronic Venous InsufficiencyPhase 4NCT01432795
Practicability of Gliding Aids for Medical Compression Stockings
A Phase 4 study testing Gliding aids for medical compression stockings in people with Chronic Venous Insufficiency and Post-thrombotic Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, Post-thrombotic Syndrome
- What is being tested?
- Gliding aids for medical compression stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 4
- 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
- > 65 years old Chronic venous insufficiency CEAP C4-6
Who cannot join
- Dementia Blindness Paraplegia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.
The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.
Read the detailed description
Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency
Stockings:
One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)
Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles
- Being tested
- Gliding aids for medical compression stockings
- Keywords
- chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment
- Medical subject headings
- Postthrombotic Syndrome, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gliding aids for medical compression stockingsDevice
Also called Gliding aids:, Easy Slide (Sigvaris), Easy Slide Caran (Sigvaris), Venotrain Glider (Bauerfeind)
Each subject tests devices:
- 3 gliding aids for stockings with closed tips
- 3 gliding aids for stockings with open tips
- 2 stocking butlers using
- 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
- 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
- 2 superimposed compression stockings class 1 (18 - 21 mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Test series of 6 types of gliding aids | Experimental | Each study subjects tests a series of gliding aids or stocking butlers:
* 4 gliding aids
* 2 stocking "butlers", one with and without handle
* 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
* 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
* 2 superimposed stockings with closed tip, compression class 1 (18-21 mmHg) Receives: Device: Gliding aids for medical compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successfully dressed medical stockings per subject
The primary end point is straight: The medical stocking is dressed (at the patient's leg) or it is not dressed. Each gliding aid and each stocking "butler" is tested with this end point.
Measured: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Secondary outcomes (1)
Patient satisfaction by gliding aid or stocking butler (score)
Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good).
Measured: Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- JH Rahn Foundation, Zurich
- Responsible party
- Sponsor
- Investigators
- Jürg Hafner, Professor, Principal investigator, Department of Dermatology, University Hospital of Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432795
- Sponsor's protocol ID
- KEK-ZH2010-0329/5
- Status last verified
- Jun 2013
- First submitted
- 2 May 2011
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sippel K, Seifert B, Hafner J. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):221-9. doi: 10.1016/j.ejvs.2014.11.005. Epub 2015 Jan 8.
PubMed 25579875
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT01432795
- Acronym / sponsor ID
- KEK-ZH2010-0329/5
- Keywords
- chronic venous insufficiency, post-thrombotic syndrome, medical compression therapy, compression stocking, gliding aid, stocking butler, adherence to treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- JH Rahn Foundation, Zurich
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Sep 2011 (estimated)
- 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.
Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.
The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.
Detailed description
Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency
Stockings:
One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)
Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test series of 6 types of gliding aids | Experimental | Device: Gliding aids for medical compression stockingsEach study subjects tests a series of gliding aids or stocking butlers: * 4 gliding aids * 2 stocking "butlers", one with and without handle * 3 medical compression stockings with open tip, compression class 3 (36-46mmHg) * 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg) * 2 superimposed stockings with closed tip, compression class 1 (18-21 mmHg) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- > 65 years old Chronic venous insufficiency CEAP C4-6
Key exclusion criteria (1 listed)
- Dementia Blindness Paraplegia
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 |
|---|---|---|
| Gliding aids for medical compression stockingsAlso: Gliding aids:, Easy Slide (Sigvaris), Easy Slide Caran (Sigvaris), Venotrain Glider (Bauerfeind)Each subject tests devices: * 3 gliding aids for stockings with closed tips * 3 gliding aids for stockings with open tips * 2 stocking butlers using * 3 medical compression stockings with open tip, compression class 3 (36-46mmHg) * 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg) * 2 superimposed compression stockings class 1 (18 - 21 mmHg) | Device | Test series of 6 types of gliding aids |
Primary outcome
Number of successfully dressed medical stockings per subject
Time frame: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
The primary end point is straight: The medical stocking is dressed (at the patient's leg) or it is not dressed. Each gliding aid and each stocking "butler" is tested with this end point.
1 secondary outcome
Patient satisfaction by gliding aid or stocking butler (score)
Time frame: Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
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 24 Jun 2013.
- Derived from this study: PubMed 25579875Sippel K, Seifert B, Hafner J. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):221-9. doi: 10.1016/j.ejvs.2014.11.005. Epub 2015 Jan 8.
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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.
Jürg Hafner, Professor principal investigator
Department of Dermatology, University Hospital of Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gliding aids for medical compression stockings in people with Chronic Venous Insufficiency and Post-thrombotic Syndrome, 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 1 inclusion and 1 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 24 Jun 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 successfully dressed medical stockings per subject (time frame: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01432795, which also lists 1 linked publication.
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 24 Jun 2013.