Edema LegDEVINe PilotNCT03928197
Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)
A study testing Tilt Test, Inbody S10 and Tape measurements in people with Edema Leg and Venous Insufficiency of Leg, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema Leg, Venous Insufficiency of Leg, Nocturia
- What is being tested?
- Tilt Test, Inbody S10 and Tape measurements
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2019to 17 May 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 25 years and 60 years
- For the volunteers with venous insuffiency: clearly visual venous insufficiency (CEAP 1 and 2)
- BMI between 24 and 30
Who cannot join
- Volunteers using medication (exception for contraception)
- Volunteers having comorbidities
- Pregnant women
- Women who menstruate on the test date
- Volunteers with an implanted elektronical device (IPG, Pacemaker)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Urology, Ghent University
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe - Trial) - Pilootstudie: definiëren Van Duidelijke Afkapwaarden Omtrent Oedeem Ter Hoogte Van de Onderste Ledematen te Gevolge Van Veneuze insufficiëntie.
Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night.
With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).
- Being tested
- Tilt Test, Inbody S10, Tape measurements, SOMNOtouchTMNIBP, Vivisol, Belgium
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilt TestBehavioural
Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes
Inbody S10Device
Bio-electrical impedance measurement every 5 minutes
Tape measurementsDevice
Every 5 minutes, circumference of every leg is measured using a tape measure
SOMNOtouchTMNIBP, Vivisol, BelgiumDevice
Continous measurement of blood pressure, heart rate and saturation
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Not described Receives: Behavioral: Tilt Test; Device: Inbody S10; Device: Tape measurements; Device: SOMNOtouchTMNIBP, Vivisol, Belgium |
| Volunteers with Venous Insuficiency | Other | Not described Receives: Behavioral: Tilt Test; Device: Inbody S10; Device: Tape measurements; Device: SOMNOtouchTMNIBP, Vivisol, Belgium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg swelling measured in cm
Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 May 2019
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LegStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928197
- Sponsor's protocol ID
- UZG 2019/0022
- Acronym
- DEVINe Pilot
- Status last verified
- Jan 2023
- First submitted
- 23 Apr 2019
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe - Trial) - Pilootstudie: definiëren Van Duidelijke Afkapwaarden Omtrent Oedeem Ter Hoogte Van de Onderste Ledematen te Gevolge Van Veneuze insufficiëntie.
- ClinicalTrials.gov ID
- NCT03928197
- Acronym / sponsor ID
- DEVINe Pilot / UZG 2019/0022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 26 Apr 2019 (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.
Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night.
With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Behavioral: Tilt Test, Device: Inbody S10, Device: Tape measurements, Device: SOMNOtouchTMNIBP, Vivisol, Belgium |
| Volunteers with Venous Insuficiency | Other | Behavioral: Tilt Test, Device: Inbody S10, Device: Tape measurements, Device: SOMNOtouchTMNIBP, Vivisol, Belgium |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 25 years and 60 years
- For the volunteers with venous insuffiency: clearly visual venous insufficiency (CEAP 1 and 2)
- BMI between 24 and 30
Key exclusion criteria (5 listed)
- Volunteers using medication (exception for contraception)
- Volunteers having comorbidities
- Pregnant women
- Women who menstruate on the test date
- Volunteers with an implanted elektronical device (IPG, Pacemaker)
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 |
|---|---|---|
| Tilt TestVolunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes | Behavioural | Healthy Volunteers, Volunteers with Venous Insuficiency |
| Inbody S10Bio-electrical impedance measurement every 5 minutes | Device | Healthy Volunteers, Volunteers with Venous Insuficiency |
| Tape measurementsEvery 5 minutes, circumference of every leg is measured using a tape measure | Device | Healthy Volunteers, Volunteers with Venous Insuficiency |
| SOMNOtouchTMNIBP, Vivisol, BelgiumContinous measurement of blood pressure, heart rate and saturation | Device | Healthy Volunteers, Volunteers with Venous Insuficiency |
Primary outcome
Leg swelling measured in cm
Time frame: 25 minutes
Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency
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 9 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tilt Test, Inbody S10 and Tape measurements in people with Edema Leg and Venous Insufficiency of Leg, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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 9 Jan 2023. 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 Belgium. 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?
Leg swelling measured in cm (time frame: 25 minutes). 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 9 Jan 2023.