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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613687
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Compression bandage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi centre, non-comparative study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 30, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Relative reduction in wound surface area (percent) [ Time Frame: 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 :
  1. Complete ulcer closure: [ Time Frame: 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

  2. Venous oedema [ Time Frame: 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).

  3. Patient quality of Life (EuroQoL 5D-5L) [ Time Frame: 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).

  4. Evolution of the periwound skin [ Time Frame: 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

  5. Safety analysis [ Time Frame: 6 weeks or last assessment ]
    Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613687


Contacts
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Contact: Batot Géraldine, PhD +33 3 80 44 28 46 g.batot@fr.urgo.com
Contact: Tacca Olivier, PhD +33 3 80 44 74 22 o.tacca@fr.urgo.com

Sponsors and Collaborators
Laboratoires URGO
Investigators
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Principal Investigator: Senet Patricia, MD Vascular dermatologist, APHP, Paris, France
Principal Investigator: Dissemond Joachim, MD Clinic for dermatology, Essen- Germany
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Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT04613687    
Other Study ID Numbers: FI-19-09-BD001
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases