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

Launched by LABORATOIRES INNOTHERA · Jul 4, 2016

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility 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.