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

URGO Group

Status

Unknown

Conditions

Venous Leg Ulcer

Treatments

Device: Compression bandage

Study type

Interventional

Funder types

Industry

Identifiers

NCT04613687

FI-19-09-BD001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.