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

Not Applicable

• Conditions: Venous Leg Ulcer
• Interventions: Device: Compression bandage

• Registration Number: NCT04613687
• Lead Sponsor: Laboratoires URGO

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-20
• Study Start: 2020-10-30
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
URGOBD001	Compression bandage	Compression bandage

Primary Outcome Measures

Name	Time	Method
Relative reduction in wound surface area (percent)	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Safety analysis	6 weeks or last assessment	Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)
Venous oedema	6 weeks or last assessment	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).
Patient quality of Life (EuroQoL 5D-5L)	6 weeks or last assessment	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).
Complete ulcer closure:	6 weeks or last assessment	The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period
Evolution of the periwound skin	6 weeks or last assessment	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