Efficacy and Safety of URGOBD001 Compression System (FUTURE)

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

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

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification

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 Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75000
    • Patricia SENET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: URGO BD001; Treatment with URGO DB001 during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12)	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; Other Names: Etiological treatment of venous disease of the lower limbs stage C6 / C6r
Active Comparator: Kit Biflex; Treatment with Kit Biflex during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12	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; Other Names: Etiological treatment of venous disease of the lower limbs stage C6 / C6r

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laboratoires URGO
• Investigators: Principal Investigator: Patricia Dr SENET, MD, Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: VLU; compression system; mixed VLU
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: ID RCB : 2021-A01874-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No