Efficacy and Safety of URGOBD001 Compression System

NCT05158764 | Completed

• 1 other identifier: ID RCB : 2021-A01874-37
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Conditions

Venous Leg Ulcer

Keywords

compression system; VLU; mixed VLU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to complete closure of the Venous Leg Ulcer (VLU)

  12-week treament period

• Safety analysis

  12-week treament period

Study Arms (2)

URGO BD001

EXPERIMENTAL

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

Kit Biflex

ACTIVE COMPARATOR

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

Interventions

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

Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Also known as: Etiological treatment of venous disease of the lower limbs stage C6 / C6r

Kit Biflex; URGO BD001

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with a systemic infection not controlled by appropriate antibiotic therapy
• 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

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

Patricia SENET

Paris, 75000, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patricia Dr SENET, MD

  Hôpitaux Universitaires Paris Est (AP-HP) - Hopital TENON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 15, 2021
• Study Start: December 3, 2021
• Primary Completion: July 6, 2023
• Study Completion: October 16, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)