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

Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers

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.

Study Overview

• Status: Unknown
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Compression bandage

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 Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Batot Géraldine, PhD; Phone Number: +33 3 80 44 28 46; Email: g.batot@fr.urgo.com
• Study Contact Backup: Name: Tacca Olivier, PhD; Phone Number: +33 3 80 44 74 22; Email: o.tacca@fr.urgo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: URGOBD001; Compression bandage	Device: Compression bandage; Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ulcer closure:	The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period	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).	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).	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	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)	6 weeks or last assessment

Collaborators and Investigators

• Sponsor: Laboratoires URGO
• Investigators: Principal Investigator: Senet Patricia, MD, Vascular dermatologist, APHP, Paris, France; Principal Investigator: Dissemond Joachim, MD, Clinic for dermatology, Essen- Germany

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 30, 2020
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (ACTUAL): November 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: FI-19-09-BD001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No