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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Laboratoires URGO
- Enrollment
- 178
- Locations
- 2
- Primary Endpoint
- Complete closure of the Venous Leg Ulcer (VLU)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Complete closure of the Venous Leg Ulcer (VLU)
Time Frame: 12-week treament period
Complete closure of the leg ulcer is defined by 100% re-epithelialization of the Venous Leg Ulcer (VLU)
Secondary Outcomes
- Safety analysis(12-week treament period)
- Time to complete closure of the Venous Leg Ulcer (VLU)(12-week treament period)