Efficacy and Safety of URGOBD001 Compression System

Not Applicable

Completed

• Conditions: Venous Leg Ulcer

• Registration Number: NCT05158764
• Lead Sponsor: Laboratoires URGO

Brief 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).

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-12-02
• Study Start: 2021-12-03
• Study First Posted: 2021-12-15
• Primary Completion: 2023-07-06
• Status Verified: 2023-10
• Study Completion: 2023-10-16
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Adult patient (≥ 18 years old), having given free, informed and written consent
• Patient affiliated to a social security scheme
• Patient agreeing to wear the study compression system daily
• Patient with an ankle circumference between 18 and 25 cm
• Target wound: stage C6 / C6r leg ulcer of the CEAP classification with a 0.8≤ ABPI≤1.3
• Target wound with an area between 1 and 20 cm2
• Target wound with age of ≤24 months

Criteria exclusion:

• Patient with a systemic infection not controlled by appropriate antibiotic therapy
• Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
• Patient with advanced stage II or stage III lymphoedema
• Patient bedridden or spending less than an hour per day standing
• Clinically infected target wound
• Cancerized target wound

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete closure of the Venous Leg Ulcer (VLU)	12-week treament period	Complete closure of the leg ulcer is defined by 100% re-epithelialization of the Venous Leg Ulcer (VLU)

Secondary Outcome Measures

Name	Time	Method
Safety analysis	12-week treament period	Nature and number of adverse event related to the use of the studied compression system (serious/ non-serious)
Time to complete closure of the Venous Leg Ulcer (VLU)	12-week treament period	Time to complete closure of the Venous Leg Ulcer (VLU) is defined as the time from inclusion to the date of complete closure

Trial Locations

Locations (1)

Patricia SENET; 🇫🇷 Paris, France