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Study of the Effect of Elastic Compression (French Class III) on Water Balance Change in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02825537
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
Biotrial
Information provided by (Responsible Party):
Laboratoires Innothera

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: Compression stocking Other: No use of compression stocking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : July 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: With use of compression stocking
Use of compression stocking during 3 consecutives days
Device: Compression stocking
A class III (20 to 36 mm Hg) elastic compression stocking according to the french classification

Without use of compression stocking
No use of compression stocking during 3 consecutives days
Other: No use of compression stocking
No use of compression stocking




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male subject aged 40 years old or more,
  2. Subject with a Body Mass Index (BMI) between 18.5 and 30 kg/m²,
  3. Subject with a body fat percentage between 11 and 27 % of his weight, as measured by impedancemetry,
  4. Subject with a muscle mass index of less than 55% of his weight, as measured by impedancemetry,
  5. Subject with a water status, as measured by impedancemetry, between + / - 5 liters of his normal value, as indicated by the impedancemetry,
  6. Healthy subject, registered in the French biomedical research volunteer national database,
  7. Subject whose lower limb measurements correspond to the size grid of the compression stocking used,
  8. Subject agreeing to abstain from alcohol intake during all hospitalization periods,
  9. 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 ...),
  10. 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),
  11. Subject accepting the constraints of the study,
  12. Subject being available during the whole period of the study,
  13. Subject who has signed the consent form after being adequately informed and receiving the information sheet,
  14. Subject affiliated to the French social security system or receiving benefits of that type.

Exclusion criteria:

  1. Subject who is a smoker or a former smoker who stopped smoking less than 6 months ago,
  2. Subject following a salt-free diet,
  3. Subject following or planning to follow a diet,
  4. Subject having a temperature ≥ 38,5°C in the morning,
  5. 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,
  6. Subject having an intestinal transit disorder that disrupts hydroelectric balance,
  7. Alcohol-dependent subject or subject with a positive alcohol breath test,
  8. Subject having a localized or general edema (a simple evening edema of the legs or ankles is accepted for inclusion),
  9. Subject suffering from insulin-dependent or uncontrolled diabetes (controlled diabetes is accepted),
  10. Subject with a serious, stabilized, or progressive illness (as judged by the investigator),
  11. Subject with hypertension or heart failure,
  12. Subject with known renal function disorders,
  13. Subject with known liver failure,
  14. Subject with venous insufficiency of clinical class C3, C4, C5 or C6 according to the Clinical / Etiological / Anatomical / Pathophysiological (CEAP) classification,
  15. Subject following long-term therapy with diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, nutritional supplements or opiates,
  16. Subject having, upon questioning or clinical examination, advanced peripheral neuropathy, skin infections, eczematous dermatitis, or weeping skin disorder of the leg,
  17. 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,
  18. 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),
  19. Subject who is participating in another clinical trial or who is in the exclusion period from a previous study,
  20. Person deprived of freedom by judicial or administrative decision, or a person hospitalized without their consent,
  21. Subject of legal age who is protected by law or under guardianship,
  22. 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,
  23. Person who works for the Contract Research Organisation or for Innothéra laboratories, or has a dependent relationship with these entities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825537


Locations
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France
Biotrial
Rennes, France, 35042
Sponsors and Collaborators
Laboratoires Innothera
Biotrial
Investigators
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Principal Investigator: Hakim Charfi, MD Biotrial
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Responsible Party: Laboratoires Innothera
ClinicalTrials.gov Identifier: NCT02825537    
Other Study ID Numbers: CVE101-15
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016