Efficacy and Safety of URGOBD001 Compression System

Venous Leg Ulcer Clinical Trial

— FUTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158764
• Other study ID #: ID RCB : 2021-A01874-37
• Status: Completed
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Laboratoires URGO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: October 16, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
France	Patricia SENET	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety analysis	Nature and number of adverse event related to the use of the studied compression system (serious/ non-serious)	12-week treament period