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

NCT02825537 | Completed

• 1 other identifier: CVE101-15
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Evolution of the total bodily fluid volume in the daytime sequence measured by impedancemetry with or without daytime use of compression stocking

  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

  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

  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

  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

  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

  adjusted over 3 consecutive days

Study Arms (2)

With use of compression stocking

EXPERIMENTAL

Use of compression stocking during 3 consecutives days

Device: Compression stocking

Without use of compression stocking

OTHER

No use of compression stocking during 3 consecutives days

Other: No use of compression stocking

Interventions

Compression stocking DEVICE

A class III (20 to 36 mm Hg) elastic compression stocking according to the french classification

With use of compression stocking

No use of compression stocking OTHER

No use of compression stocking

Without use of compression stocking

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,
• Alcohol-dependent subject or subject with a positive alcohol breath test,
• 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,

Sponsors & Collaborators

• Laboratoires Innothera: lead
• Biotrial: collaborator

Study Sites (1)

Biotrial

Rennes, 35042, France

Location

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Hakim Charfi, MD

  Biotrial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

FR (1)