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Efficacy and Safety of URGOBD001 Compression System (FUTURE)

Primary Purpose

Venous Leg Ulcer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring compression system, VLU, mixed VLU

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Patricia SENET

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

URGO BD001

Kit Biflex

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Safety analysis

Nature and number of adverse event related to the use of the studied compression system (serious/ non-serious)

Full Information

NCT ID

NCT05158764

First Posted

October 29, 2021

Last Updated

October 16, 2023

Sponsor

Laboratoires URGO

1. Study Identification

Unique Protocol Identification Number

NCT05158764

Brief Title

Efficacy and Safety of URGOBD001 Compression System

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2021 (Actual)

Primary Completion Date

July 6, 2023 (Actual)

Study Completion Date

October 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires URGO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

Keywords

compression system, VLU, mixed VLU

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

URGO BD001

Arm Type

Experimental

Arm Description

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

Arm Title

Kit Biflex

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete closure of the Venous Leg Ulcer (VLU)

Description

Complete closure of the leg ulcer is defined by 100% re-epithelialization of the Venous Leg Ulcer (VLU)

Time Frame

12-week treament period

Secondary Outcome Measure Information:

Title

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

Description

Time to complete closure of the Venous Leg Ulcer (VLU) is defined as the time from inclusion to the date of complete closure

Time Frame

12-week treament period

Title

Safety analysis

Description

Nature and number of adverse event related to the use of the studied compression system (serious/ non-serious)

Time Frame

12-week treament period

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Dr SENET, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Patricia SENET

City

Paris

ZIP/Postal Code

75000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of URGOBD001 Compression System

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