Study of the Effect of an Elastic Compression Medical Device, on Water Balance Change in Healthy Subjects

Inclusion criteria

• Male subject aged 40 years old or more.
• Subject with a body mass index (BMI) between 18.5 and 30 kg/m².
• Healthy subject, registered in the French biomedical research volunteer national file.
• Subject for whom both lower limb measurements correspond to the size grid of the IMD used.
• Subject agreeing to abstain from alcohol intake from 48 hours before P1D-2, during all hospitalization periods and during the outpatient period.
• Subject accepting to proceed with a COVID-19 test at the time of each inpatient period, and for whom the result is negative
• Subject accepting to protect himself in an appropriate way to avoid COVID-19 infection during the outpatient period.
• Subject practicing under 5 hours of intense physical activity per week, on average, in the 4 weeks preceding the screening visit (e.g. no marathon training or military training).
• Subject agreeing to abstain from any strenuous activity, especially sports, from the screening visit to the end of clinical investigation (including during the outpatient period).
• Subject accepting the constraints of the clinical investigation.
• Subject being available for the duration of the clinical investigation.
• Subject who has signed the informed consent form (ICF) after being adequately informed and receiving the information sheet.
• Subject affiliated with the French social security system or receiving benefits of that type.

Exclusion criteria

(non-inclusion criteria):

• 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 either a slimming diet or any specific diet that could not be followed during hospitalization.
• Subject having a temperature > 38.0°C at screening or in the morning of D-2 and D1 of the first period (P1).
• Subject having, upon clinical examination, an abnormal systolic blood pressure (SBP), diastolic blood pressure (DBP) or heart rate (HR) judged clinically significant by the Investigator.
• Subject having an intestinal transit disorder that disrupts hydroelectric balance.
• 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 having a medical background of deep and superficial vein thrombosis.
• 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 legs.
• Subject with a medical contraindication to compression therapy according to the interview or clinical examination: phlegmatia coerulea dolens, septic thrombosis, intolerance to the IMD, allergic reaction to any component, arteritis obliterans of lower limbs, advanced diabetic microangiopathy.
• Subject with active implants, such as a pacemaker or artificial heart type, 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/clinical investigation.
• Person deprived of freedom by judicial or administrative decision, or a person hospitalized without his 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 CRO or for Laboratoires Innothera, or has a dependent relationship with these entities.