Clinical trial NCT04613687: Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)
Official title: Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi centre, non-comparative study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relative reduction in wound surface area (percent)
timeFrame: 6 weeks
Secondary outcomes:
measure: Complete ulcer closure:
timeFrame: 6 weeks or last assessment
measure: Venous oedema
timeFrame: 6 weeks or last assessment
measure: Patient quality of Life (EuroQoL 5D-5L)
timeFrame: 6 weeks or last assessment
measure: Evolution of the periwound skin
timeFrame: 6 weeks or last assessment
measure: Safety analysis
timeFrame: 6 weeks or last assessment
Other outcomes:
Locations:
Study officials:
affiliation: Vascular dermatologist, APHP, Paris, France
name: Senet Patricia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for dermatology, Essen- Germany
name: Dissemond Joachim, MD
role: PRINCIPAL_INVESTIGATOR
References: