Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
NCT ID: NCT04159844
Last Updated: 2019-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2019-09-03
2019-11-29
Brief Summary
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Detailed Description
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The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* URGOBD001 SSI compared with the SSI of a short stretch bandage
* URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage
* URGOBD001 SSI compared with the SSI of a multi component bandage.
OTHER
NONE
Study Groups
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Short stretch bandage
Application with 50% overlap in combinaison with wading
URGOBD001
Application with 50% overlapping
Multi componant bandage
Application with 50% overlap
URGOBD001
Application with 50% overlapping
Short stretch bandage bis
Application with 50% overlap in combinaison with wading
URGOBD001 associated with wading
Application with 50% overlapping in association with wading
Interventions
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URGOBD001
Application with 50% overlapping
URGOBD001 associated with wading
Application with 50% overlapping in association with wading
Eligibility Criteria
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Inclusion Criteria
* Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
* Subject presenting a venous doppler of the lower limbs without detectable anomaly
* Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
* Subject accepting to wear a compressive system on both legs for a period of three days.
Exclusion Criteria
* Subject with type I or II diabetes
* Subject with lipoedema and / or dismorphic leg
* Subject presenting ankle ankylosis
18 Years
65 Years
ALL
Yes
Sponsors
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Laboratoires URGO
INDUSTRY
Responsible Party
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Principal Investigators
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Benigni JP, MD
Role: PRINCIPAL_INVESTIGATOR
Intertek France clinical studies
Locations
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Intertek France Clinical studies
Paris, , France
Countries
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Central Contacts
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Other Identifiers
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F-19-06-BD001
Identifier Type: -
Identifier Source: org_study_id
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