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

Healthy Subjects Clinical Trial

— FUSION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159844
• Other study ID #: F-19-06-BD001
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: October 2019
• Source: Laboratoires URGO
• Contact: Batot Géraldine, PhD
• Phone: +33 3 80 44 28 46
• Email: g.batot[@]fr.urgo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• URGOBD001
Application with 50% overlapping
• URGOBD001 associated with wading
Application with 50% overlapping in association with wading

Locations

Country	Name	City	State
France	Intertek France Clinical studies	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI(Static Stiffness Index) = 10 mmHg	% of subject with a SSI= 10 mmHg	Hour 48 after the application
Secondary	SSI (Static Stiffness Index)	Evolution over time	From Hour 0 (Baseline) to Hour 72 (end of study) after application
Secondary	Interface pressure under the bandage	Evolution over time	From Hour 0 (Baseline) to Hour 72 after application
Secondary	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