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

November 8, 2019 updated by: Laboratoires URGO
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.

Study Overview

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

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Paris, France, 75013
        • Recruiting
        • Intertek France Clinical studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Short stretch bandage
Application with 50% overlap in combinaison with wading
Application with 50% overlapping
ACTIVE_COMPARATOR: Multi componant bandage
Application with 50% overlap
Application with 50% overlapping
ACTIVE_COMPARATOR: Short stretch bandage bis
Application with 50% overlap in combinaison with wading
Application with 50% overlapping in association with wading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSI(Static Stiffness Index) ≥ 10 mmHg
Time Frame: Hour 48 after the application
% 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)
Time Frame: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Evolution over time
From Hour 0 (Baseline) to Hour 72 (end of study) after application
Interface pressure under the bandage
Time Frame: From Hour 0 (Baseline) to Hour 72 after application
Evolution over time
From Hour 0 (Baseline) to Hour 72 after application
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)
From Hour 0 (Baseline) to Hour 72 (end of study) after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benigni JP, MD, Intertek France Clinical studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2019

Primary Completion (ANTICIPATED)

November 29, 2019

Study Completion (ANTICIPATED)

November 29, 2019

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (ACTUAL)

November 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • F-19-06-BD001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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