NCT04613687

Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

Detailed description

The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression. The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Compression bandage	Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

Timeline

• Start date: 2020-10-30
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2020-11-03
• Last updated: 2020-11-03