VaricosityRECVENNCT02641600
Elastic Compression in Chronic Venous Disease
A study testing Elastic stockings in people with Varicosity, run by University of Patras at 1 site in Greece.
Trial summary
Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicosity
- What is being tested?
- Elastic stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2015to Apr 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary varicose veins causing pain/ache located only at the calf level
Who cannot join
- Venous ulceration
- Dermatitis
- Itching
- Superficial vein thrombosis
- Peripheral arterial disease
- Symptoms of non-venous origin
- Previous use of elastic stockings
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras
Pátrai, Achaia, 26504
Stavros K Kakkos, MD, PhD, 302613603406, kakkos@upatras.gr
Ioannis A Tsolakis, MD, PhD, 302613603360, itsolak@upatras.gr
About this study
Official title: Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)
Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings
Read the detailed description
Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.
- Conditions
- Varicosity
- Being tested
- Elastic stockings, Placebo stockings
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic stockingsDevice
Use of elastic stockings to alleviate patient symptoms
Placebo stockingsDevice
Placebo stocking with pressure applied to the legs
| Study group | Role | What they receive |
|---|---|---|
| Elastic stockings | Active comparator | Class 1 elastic stockings (18-21 mmHg) Receives: Device: Elastic stockings |
| Placebo stockings | Placebo comparator | Placebo stockings (0 mmHg) Receives: Device: Placebo stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/ache assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Secondary outcomes (10)
revised Venous Clinical Severity Score (rVCSS)
revised Venous Clinical Severity Score
Measured: One week
Heaviness assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Night cramps assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10)
Measured: One week
Swelling sensation assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Burning sensation assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Paresthesia assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Restless legs assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10)
Measured: One week
throbbing assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10)
Measured: One week
insomnia assessed using a visual analogue scale (0-10)
Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10)
Measured: One week
Ankle circumference
This will be measured just above the malleoli, at the smallest point.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricosityStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kakkos, University of Patras
- Investigators
- Stavros K Kakkos, MD, PhD, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641600
- Sponsor's protocol ID
- 35/18.02.2015
- Acronym
- RECVEN
- Status last verified
- May 2016
- First submitted
- 21 Dec 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)
- ClinicalTrials.gov ID
- NCT02641600
- Acronym / sponsor ID
- RECVEN / 35/18.02.2015
- Conditions
- Varicosity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 29 Dec 2015 (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.
Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings
Detailed description
Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic stockings | Active comparator | Device: Elastic stockingsClass 1 elastic stockings (18-21 mmHg) |
| Placebo stockings | Placebo comparator | Device: Placebo stockingsPlacebo stockings (0 mmHg) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary varicose veins causing pain/ache located only at the calf level
Key exclusion criteria (7 listed)
- Venous ulceration
- Dermatitis
- Itching
- Superficial vein thrombosis
- Peripheral arterial disease
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 |
|---|---|---|
| Elastic stockingsUse of elastic stockings to alleviate patient symptoms | Device | Elastic stockings |
| Placebo stockingsPlacebo stocking with pressure applied to the legs | Device | Placebo stockings |
Primary outcome
Pain/ache assessed using a visual analogue scale (0-10)
Time frame: One week
Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10)
10 secondary outcomes
revised Venous Clinical Severity Score (rVCSS)
Time frame: One week
Heaviness assessed using a visual analogue scale (0-10)
Time frame: One week
Night cramps assessed using a visual analogue scale (0-10)
Time frame: One week
Swelling sensation assessed using a visual analogue scale (0-10)
Time frame: One week
Burning sensation assessed using a visual analogue scale (0-10)
Time frame: One week
Paresthesia assessed using a visual analogue scale (0-10)
Time frame: One week
Restless legs assessed using a visual analogue scale (0-10)
Time frame: One week
throbbing assessed using a visual analogue scale (0-10)
Time frame: One week
insomnia assessed using a visual analogue scale (0-10)
Time frame: One week
Ankle circumference
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Stavros K Kakkos, MD, PhD principal investigator
University of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic stockings in people with Varicosity, run by University of Patras at 1 site in Greece.
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 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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 Greece. 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. Some participants in this study may receive a placebo. 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 Stavros K Kakkos, MD, PhD, RVT (302613603406, kakkos@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain/ache assessed using a visual analogue scale (0-10) (time frame: One week). 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 12 May 2016.