Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)
NCT ID: NCT04613687
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2020-10-30
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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URGOBD001
Compression bandage
Compression bandage
Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
Interventions
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Compression bandage
Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Laboratoires URGO
INDUSTRY
Responsible Party
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Principal Investigators
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Senet Patricia, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular dermatologist, APHP, Paris, France
Dissemond Joachim, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for dermatology, Essen- Germany
Central Contacts
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Other Identifiers
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FI-19-09-BD001
Identifier Type: -
Identifier Source: org_study_id