Efficacy and Safety of URGOBD001 Compression System (FUTURE)

URGO Group

Status: Completed

Conditions: Venous Leg Ulcer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05158764

ID RCB : 2021-A01874-37

Details and patient eligibility

About

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

Full 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).

Enrollment: 178 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

URGO BD001

Experimental group

Description:

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

Treatment:

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

Kit Biflex

Active Comparator group

Description:

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

Treatment:

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