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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

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date August 24, 2016
Study Start Date  ICMJE July 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effect of Elastic Compression (French Class III) on Water Balance Change in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Device: Compression stocking
    A class III (20 to 36 mm Hg) elastic compression stocking according to the french classification
  • Other: No use of compression stocking
    No use of compression stocking
Study Arms  ICMJE
  • Experimental: With use of compression stocking
    Use of compression stocking during 3 consecutives days
    Intervention: Device: Compression stocking
  • Without use of compression stocking
    No use of compression stocking during 3 consecutives days
    Intervention: Other: No use of compression stocking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2016)
22
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825537
Other Study ID Numbers  ICMJE CVE101-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoires Innothera
Study Sponsor  ICMJE Laboratoires Innothera
Collaborators  ICMJE Biotrial
Investigators  ICMJE
Principal Investigator: Hakim Charfi, MD Biotrial
PRS Account Laboratoires Innothera
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP