NCT04159844

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	URGOBD001	Application with 50% overlapping
DEVICE	URGOBD001 associated with wading	Application with 50% overlapping in association with wading

Timeline

• Start date: 2019-09-03
• Primary completion: 2019-11-29
• Completion: 2019-11-29
• First posted: 2019-11-12
• Last updated: 2019-11-12

Locations

1 site across 1 country: France