- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159844
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects (FUSION)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Batot Géraldine, PhD
- Phone Number: +33 3 80 44 28 46
- Email: g.batot@fr.urgo.com
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Intertek France Clinical studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Benigni JP, MD, Intertek France Clinical studies
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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