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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 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO

Tracking Information
First Submitted Date  ICMJE October 24, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE September 3, 2019
Estimated Primary Completion Date November 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
SSI(Static Stiffness Index) ≥ 10 mmHg [ Time Frame: Hour 48 after the application ]
% of subject with a SSI≥ 10 mmHg
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • SSI (Static Stiffness Index) [ Time Frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application ]
    Evolution over time
  • Interface pressure under the bandage [ Time Frame: From Hour 0 (Baseline) to Hour 72 after application ]
    Evolution over time
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
Official Title  ICMJE Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Device: URGOBD001
    Application with 50% overlapping
  • Device: URGOBD001 associated with wading
    Application with 50% overlapping in association with wading
Study Arms  ICMJE
  • Active Comparator: Short stretch bandage
    Application with 50% overlap in combinaison with wading
    Intervention: Device: URGOBD001
  • Active Comparator: Multi componant bandage
    Application with 50% overlap
    Intervention: Device: URGOBD001
  • Active Comparator: Short stretch bandage bis
    Application with 50% overlap in combinaison with wading
    Intervention: Device: URGOBD001 associated with wading
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 29, 2019
Estimated Primary Completion Date November 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Batot Géraldine, PhD +33 3 80 44 28 46 g.batot@fr.urgo.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159844
Other Study ID Numbers  ICMJE F-19-06-BD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoires URGO
Study Sponsor  ICMJE Laboratoires URGO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benigni JP, MD Intertek France clinical studies
PRS Account Laboratoires URGO
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP