Venous InsufficiencyPhase 2/3NCT00196443
The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease
A Phase 2/3 study testing urea contained compressing stockings and compressing stockings in people with Venous Insufficiency, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- urea contained compressing stockings and compressing stockings
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2005to Jul 2005
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clincial diagnosis of chronic venous insufficiency
- Age: 18-80 years
- Patient's information and willingness to participate
Who cannot join
- Age under 18 years
- Lower limp edema not caused by venous insufficiency
- Acute deep venous thrombosis
- Arterial occlusive disease
- Diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion
- immobile Patients
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
Greifswald, Fleischmannstr. 42-44, 17475
About this study
Official title: Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency
The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.
- Conditions
- Venous Insufficiency
- Being tested
- urea contained compressing stockings, compressing stockings
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urea contained compressing stockingsDevice
compressing stockingsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
skin moisture at day 0 and day 7
loss of water throughout epidermis at day 0 and day 7
throatiness of epidermis at day 0 and day 7
Secondary outcomes (1)
compliance of patients at every day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Bauerfeind AG, Zeulenroda, Germany
- Investigators
- Michael Jünger, Prof. Dr., Principal investigator, Clinic and Polyclinic of Dermatology, University of GreifswaldAndrea Ladwig, Study chair, Clinic and Polyclinic of Dermatology, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196443
- Sponsor's protocol ID
- Bau-Phleb-17032005
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT00196443
- Acronym / sponsor ID
- Bau-Phleb-17032005
- Conditions
- Venous Insufficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Bauerfeind AG, Zeulenroda, Germany
- Study start
- Jun 2005
- Study completion
- Jul 2005
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clincial diagnosis of chronic venous insufficiency
- Age: 18-80 years
- Patient's information and willingness to participate
Key exclusion criteria (7 listed)
- Age under 18 years
- Lower limp edema not caused by venous insufficiency
- Acute deep venous thrombosis
- Arterial occlusive disease
- Diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion
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 |
|---|---|---|
| urea contained compressing stockings | Device | – |
| compressing stockings | Device | – |
Primary outcome
skin moisture at day 0 and day 7
loss of water throughout epidermis at day 0 and day 7
throatiness of epidermis at day 0 and day 7
1 secondary outcome
compliance of patients at every day of intervention
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 20 Sep 2005.
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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.
Michael Jünger, Prof. Dr. principal investigator
Clinic and Polyclinic of Dermatology, University of Greifswald
Andrea Ladwig study chair
Clinic and Polyclinic of Dermatology, University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing urea contained compressing stockings and compressing stockings in people with Venous Insufficiency, run by University Medicine Greifswald at 1 site in Germany.
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 20 Sep 2005. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
skin moisture at day 0 and day 7. The study lists 3 primary outcomes in all. 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 20 Sep 2005.