Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
NCT ID: NCT06135987
Last Updated: 2023-11-18
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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RECRUITING
600 participants
OBSERVATIONAL
2022-06-24
2024-10-31
Brief Summary
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Detailed Description
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The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)
Clinical evaluation of the dressing in the local treatment of chronic wounds (DFU and VLU)
Eligibility Criteria
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Inclusion Criteria
* Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
* Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
* Patient can be followed over 12 weeks by the investigator, according to his/her practices
* Patient able to participate in the study and complete a self-questionnaire without difficulty
Exclusion Criteria
* Cancerous wound
* Fistulous wound revealing a deep abscess
* Presence of dry necrosis partially or completely covering the wound bed
* Infected wound
* Osteitis
* Critical or acute ischemia
* Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit
* Patient with known sensitivity to one of the studied dressings components
* Pregnant or breastfeeding patient
* Patient under the protection of justice or under guardianship or deprived of liberty
18 Years
ALL
No
Sponsors
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Laboratoires URGO
INDUSTRY
Responsible Party
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Locations
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Pr Agnès HARTEMANN
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A02414-37
Identifier Type: -
Identifier Source: org_study_id
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