Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

Laboratoires URGO52 enrolled

Overview

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression. The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Leg Ulcer

Interventions

Compression bandageDEVICE

Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3), * Wound in granulation phase (granulation tissue ≥50%), * Wound at least 3 cm away from any edge of another wound, * VLU between 2 and 20 cm2 in surface area, * VLU duration between 1 to 24 months. Exclusion Criteria: * Patient under guardianship or protection of vulnerable adult, * Patient with known allergy to any components of the tested compression system, * Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period, * Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor, * Patient with non-controlled systemic infection by a suitable antibiotic therapy, * Patient who had a deep vein thrombosis within 3 months prior to the inclusion, * Patient with a lymphedema due to lymphatic obstruction, * Diabetic patient with advanced diagnosed microangiopathy, * Bedridden patient, or those spending less than one hour per day on their feet, * Wound covered partially or totally with necrotic tissue, * Clinically infected wound, * Wound requiring surgical treatment or for which a surgery is scheduled during the study period, * Cancerous lesions.

Outcomes

Primary Outcomes

Relative reduction in wound surface area (percent)

Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = \[(SW6 - SD0)/SD0\] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6

Time frame: 6 weeks

Secondary Outcomes

Complete ulcer closure:

The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period

Time frame: 6 weeks or last assessment

Venous oedema

Oedema reduction from baseline (D0) and last assessment by measuring the limb circumference (in cm), using a tape: * Ankle circumference at the reference point B (smallest perimeter of the leg, 3 cm above medial malleolus, * Calf circumference at the reference point C (maximum perimeter of the calf).

Time frame: 6 weeks or last assessment

Patient quality of Life (EuroQoL 5D-5L)

EuroQoL 5D-5L between baseline and at last visit. The questionnaire essentially consists of a descriptive system including 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analogue scale (EQ VAS) from "the worst health you can imagine" (0) to "the best health you can imagine" (100).

Time frame: 6 weeks or last assessment

Evolution of the periwound skin

Evolution of the peri-wound skin at each visit according to the following parameters: * Healthy * Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other

Time frame: 6 weeks or last assessment

Safety analysis

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

Central Contacts

Batot Géraldine, PhD

CONTACT

+33 3 80 44 28 46 g.batot@fr.urgo.com

Tacca Olivier, PhD

CONTACT

+33 3 80 44 74 22 o.tacca@fr.urgo.com

Data from ClinicalTrials.gov

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