Healthy SubjectsNCT02825537
Study of the Effect of Elastic Compression (French Class III) on Water Balance Change in Healthy Subjects
A study testing Compression stocking and No use of compression stocking in people with Healthy Subjects, run by Laboratoires Innothera at 1 site in France.
Trial summary
The main objective of this study is to compare precisely, under standardized test conditions, water balance changes in healthy subjects with or without the daytime use of compression stocking. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Compression stocking and No use of compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Aug 2016
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subject aged 40 years old or more,
- Subject with a Body Mass Index (BMI) between 18.5 and 30 kg/m²,
- Subject with a body fat percentage between 11 and 27 % of his weight, as measured by impedancemetry,
- Subject with a muscle mass index of less than 55% of his weight, as measured by impedancemetry,
- Subject with a water status, as measured by impedancemetry, between + / - 5 liters of his normal value, as indicated by the impedancemetry,
- Healthy subject, registered in the French biomedical research volunteer national database,
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- Subject whose lower limb measurements correspond to the size grid of the compression stocking used,
- Subject agreeing to abstain from alcohol intake during all hospitalization periods,
- Subject practicing under 5 hours of intense physical activity per week, on average, in the 4 weeks preceding the screening visit (marathon training, military training ...),
- Subject agreeing to abstain from any strenuous activity , especially sports, from the screening visit to the end of study (including during the out-patient period),
- Subject accepting the constraints of the study,
- Subject being available during the whole period of the study,
- Subject who has signed the consent form after being adequately informed and receiving the information sheet,
- Subject affiliated to the French social security system or receiving benefits of that type.
Who cannot join
- Subject who is a smoker or a former smoker who stopped smoking less than 6 months ago,
- Subject following a salt-free diet,
- Subject following or planning to follow a diet,
- Subject having a temperature ≥ 38,5°C in the morning,
- Subject having, upon clinical examination, a systolic blood pressure (SBP) < 91 mmHg or > 139 mmHg, a diastolic blood pressure (DBP) < 41 mmHg or > 89 mmHg, or a heart rate (HR) < 40 bpm or > 100 bpm, and judged clinically significant by the investigator,
- Subject having an intestinal transit disorder that disrupts hydroelectric balance,
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- Alcohol-dependent subject or subject with a positive alcohol breath test,
- Subject having a localized or general edema (a simple evening edema of the legs or ankles is accepted for inclusion),
- Subject suffering from insulin-dependent or uncontrolled diabetes (controlled diabetes is accepted),
- Subject with a serious, stabilized, or progressive illness (as judged by the investigator),
- Subject with hypertension or heart failure,
- Subject with known renal function disorders,
- Subject with known liver failure,
- Subject with venous insufficiency of clinical class C3, C4, C5 or C6 according to the Clinical / Etiological / Anatomical / Pathophysiological (CEAP) classification,
- Subject following long-term therapy with diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, nutritional supplements or opiates,
- Subject having, upon questioning or clinical examination, advanced peripheral neuropathy, skin infections, eczematous dermatitis, or weeping skin disorder of the leg,
- Subject with a medical contraindication to compression therapy according to the interview or clinical examination: phlegmatia coerulea dolens, septic thrombosis, intolerance to the product including the self-supporting band, allergic reaction to any component, arteritis obliterans of lower limbs, advanced diabetic microangiopathy,
- Subject with active implants, such as a pacemaker or other mechanical heart device , and non-active implants, for example a hip prosthesis (dental implants are authorized),
- Subject who is participating in another clinical trial or who is in the exclusion period from a previous study,
- Person deprived of freedom by judicial or administrative decision, or a person hospitalized without their consent,
- Subject of legal age who is protected by law or under guardianship,
- Subject with a current mental or psychiatric disorder or a history of mental or psychiatric disorder, or any other factor limiting the collection of informed consent,
- Person who works for the Contract Research Organisation or for Innothéra laboratories, or has a dependent relationship with these entities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Class III Elastic Venous Compression Focused on 33 mmHg on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study
The main objective of this study is to compare precisely, under standardized test conditions, water balance changes in healthy subjects with or without the daytime use of compression stocking.
- Conditions
- Healthy Subjects
- Being tested
- Compression stocking, No use of compression stocking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingDevice
A class III (20 to 36 mm Hg) elastic compression stocking according to the french classification
No use of compression stockingOther
No use of compression stocking
| Study group | Role | What they receive |
|---|---|---|
| With use of compression stocking | Experimental | Use of compression stocking during 3 consecutives days Receives: Device: Compression stocking |
| Without use of compression stocking | Other | No use of compression stocking during 3 consecutives days Receives: Other: No use of compression stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the total bodily fluid volume in the daytime sequence measured by impedancemetry with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Secondary outcomes (8)
Evolution of the water balance in daytime sequence,in night sequence and on a 24h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of the subject's weight (in kilograms), in daytime sequence, in night sequence and on a 24 h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of the volume of urine determined by weight (in kilograms),in daytime sequence, in night sequence and a 24h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution days of the neck circumference (in centimeter) in a dynamic sequence, in supine sequence and on a 24h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of leg perimeters (in centimeter) in 3 points in dynamic sequence, in supine sequence , and over 24h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of the time and volume of the first urine after H0 determined by weight (in kilograms) with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of the quantity of NaCl excreted in urine in daytime sequence, in night sequence, and over 24 h sequence with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Evolution of the total bodily fluid volume in night sequence and on a 24h sequence measured by impedancemetry with or without daytime use of compression stocking
Measured: adjusted over 3 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Innothera
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Responsible party
- Sponsor
- Investigators
- Hakim Charfi, MD, Principal investigator, Biotrial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825537
- Sponsor's protocol ID
- CVE101-15
- Status last verified
- Aug 2016
- First submitted
- 30 Jun 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Class III Elastic Venous Compression Focused on 33 mmHg on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study
- ClinicalTrials.gov ID
- NCT02825537
- Acronym / sponsor ID
- CVE101-15
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Laboratoires InnotheraIndustry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Jul 2016 (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 main objective of this study is to compare precisely, under standardized test conditions, water balance changes in healthy subjects with or without the daytime use of compression stocking.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With use of compression stocking | Experimental | Device: Compression stockingUse of compression stocking during 3 consecutives days |
| Without use of compression stocking | Other | Other: No use of compression stockingNo use of compression stocking during 3 consecutives days |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male subject aged 40 years old or more,
- Subject with a Body Mass Index (BMI) between 18.5 and 30 kg/m²,
- Subject with a body fat percentage between 11 and 27 % of his weight, as measured by impedancemetry,
- Subject with a muscle mass index of less than 55% of his weight, as measured by impedancemetry,
- Subject with a water status, as measured by impedancemetry, between + / - 5 liters of his normal value, as indicated by the impedancemetry,
Key exclusion criteria (23 listed)
- Subject who is a smoker or a former smoker who stopped smoking less than 6 months ago,
- Subject following a salt-free diet,
- Subject following or planning to follow a diet,
- Subject having a temperature ≥ 38,5°C in the morning,
- Subject having, upon clinical examination, a systolic blood pressure (SBP) < 91 mmHg or > 139 mmHg, a diastolic blood pressure (DBP) < 41 mmHg or > 89 mmHg, or a heart rate (HR) < 40 bpm or > 100 bpm, and judged clinically significant by the investigator,
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 |
|---|---|---|
| Compression stockingA class III (20 to 36 mm Hg) elastic compression stocking according to the french classification | Device | With use of compression stocking |
| No use of compression stockingNo use of compression stocking | Other | Without use of compression stocking |
Primary outcome
Evolution of the total bodily fluid volume in the daytime sequence measured by impedancemetry with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
8 secondary outcomes
Evolution of the water balance in daytime sequence,in night sequence and on a 24h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of the subject's weight (in kilograms), in daytime sequence, in night sequence and on a 24 h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of the volume of urine determined by weight (in kilograms),in daytime sequence, in night sequence and a 24h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution days of the neck circumference (in centimeter) in a dynamic sequence, in supine sequence and on a 24h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of leg perimeters (in centimeter) in 3 points in dynamic sequence, in supine sequence , and over 24h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of the time and volume of the first urine after H0 determined by weight (in kilograms) with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of the quantity of NaCl excreted in urine in daytime sequence, in night sequence, and over 24 h sequence with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive days
Evolution of the total bodily fluid volume in night sequence and on a 24h sequence measured by impedancemetry with or without daytime use of compression stocking
Time frame: adjusted over 3 consecutive 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 24 Aug 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.
Hakim Charfi, MD principal investigator
Biotrial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocking and No use of compression stocking in people with Healthy Subjects, run by Laboratoires Innothera at 1 site in France.
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 14 inclusion and 23 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 Aug 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 France. 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?
Evolution of the total bodily fluid volume in the daytime sequence measured by impedancemetry with or without daytime use of compression stocking (time frame: adjusted over 3 consecutive days). 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 24 Aug 2016.