Efficacy and Safety of URGOBD001 Compression System

NCT ID: NCT05158764

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2023-10-16

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).

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URGO BD001

Treatment with URGO DB001 during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12)

Group Type: EXPERIMENTAL

Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification

Intervention Type: DEVICE

Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Kit Biflex

Treatment with Kit Biflex during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12

Group Type: ACTIVE_COMPARATOR

Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification

Intervention Type: DEVICE

Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires URGO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Dr SENET, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires Paris Est (AP-HP) - Hopital TENON

Locations

Patricia SENET

Paris, , France

Countries

France

Other Identifiers

ID RCB : 2021-A01874-37

Identifier Type: -

Identifier Source: org_study_id