Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

Study Overview
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Brief Summary
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This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

Detailed Description
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Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness. 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).

Official Title
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Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Device: URGOBD001
* Device: URGOBD001 associated with wading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with a body mass index of less than 30 (BMI = kg / m²), 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 chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases) Subject with type I or II diabetes Subject with lipoedema and / or dismorphic leg Subject presenting ankle ankylosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 separate sets : 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short stretch bandage<br>Application with 50% overlap in combinaison with wading | Device: URGOBD001<br>* Application with 50% overlapping<br>|
| Active Comparator: Multi componant bandage<br>Application with 50% overlap | Device: URGOBD001<br>* Application with 50% overlapping<br>|
| Active Comparator: Short stretch bandage bis<br>Application with 50% overlap in combinaison with wading | Device: URGOBD001 associated with wading<br>* Application with 50% overlapping in association with wading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI(Static Stiffness Index) ≥ 10 mmHg | % of subject with a SSI≥ 10 mmHg | Hour 48 after the application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI (Static Stiffness Index) | Evolution over time | From Hour 0 (Baseline) to Hour 72 (end of study) after application | 
| Interface pressure under the bandage | Evolution over time | From Hour 0 (Baseline) to Hour 72 after application | 
| Slippage of the bandage in cm | Assessed by measuring with a tape at each time (i) the length (L) from the top of the bandage to the floor, Slippage (cm) = L(Time 0) - L (Time i) | From Hour 0 (Baseline) to Hour 72 (end of study) after application |