Efficacy and Safety of URGOBD001 Compression System

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Venous Leg Ulcer

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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URGO BD001<br>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<br>* Etiological treatment of venous disease of the lower limbs stage C6 / C6r<br>* Other names: Etiological treatment of venous disease of the lower limbs stage C6 / C6r;|
| Active Comparator: Kit Biflex<br>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<br>* Etiological treatment of venous disease of the lower limbs stage C6 / C6r<br>* Other names: Etiological treatment of venous disease of the lower limbs stage C6 / C6r;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression system, VLU, mixed VLU