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Trial record 71 of 83817 for:    subjects

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

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ClinicalTrials.gov Identifier: NCT04159844
Recruitment Status : Recruiting
First Posted : November 11, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: URGOBD001 Device: URGOBD001 associated with wading Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : November 29, 2019

Arm Intervention/treatment
Active Comparator: Short stretch bandage
Application with 50% overlap in combinaison with wading
Device: URGOBD001
Application with 50% overlapping

Active Comparator: Multi componant bandage
Application with 50% overlap
Device: URGOBD001
Application with 50% overlapping

Active Comparator: Short stretch bandage bis
Application with 50% overlap in combinaison with wading
Device: URGOBD001 associated with wading
Application with 50% overlapping in association with wading




Primary Outcome Measures :
  1. SSI(Static Stiffness Index) ≥ 10 mmHg [ Time Frame: Hour 48 after the application ]
    % of subject with a SSI≥ 10 mmHg


Secondary Outcome Measures :
  1. SSI (Static Stiffness Index) [ Time Frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application ]
    Evolution over time

  2. Interface pressure under the bandage [ Time Frame: From Hour 0 (Baseline) to Hour 72 after application ]
    Evolution over time

  3. Slippage of the bandage in cm [ Time Frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application ]
    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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159844


Contacts
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Contact: Batot Géraldine, PhD +33 3 80 44 28 46 g.batot@fr.urgo.com

Locations
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France
Intertek France Clinical studies Recruiting
Paris, France, 75013
Sponsors and Collaborators
Laboratoires URGO
Investigators
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Principal Investigator: Benigni JP, MD Intertek France clinical studies

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Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT04159844     History of Changes
Other Study ID Numbers: F-19-06-BD001
First Posted: November 11, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No