NCT05158764

Efficacy and Safety of URGOBD001 Compression System

Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

Detailed description

This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification. This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers. A planimetric survey of the studied VLU is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification	Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-07-06
• Completion: 2023-10-16
• First posted: 2021-12-15
• Last updated: 2023-10-17

Locations

1 site across 1 country: France