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

URGO Group

Status: Unknown

Conditions: Healthy Subjects

Treatments: Device: URGOBD001 associated with wading; Device: URGOBD001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159844

F-19-06-BD001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Short stretch bandage

Active Comparator group

Description:

Application with 50% overlap in combinaison with wading

Treatment:

Device: URGOBD001

Multi componant bandage

Active Comparator group

Description:

Application with 50% overlap

Treatment:

Device: URGOBD001

Short stretch bandage bis

Active Comparator group

Description:

Application with 50% overlap in combinaison with wading

Treatment:

Device: URGOBD001 associated with wading