Status:
UNKNOWN
Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
Lead Sponsor:
Laboratoires URGO
Conditions:
Real Life Study
TLC-NOSF Dressings
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neurop...
Detailed Description
This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose. The study will be carrie...
Eligibility Criteria
Inclusion
- Adult outpatient having signed informed consent
- 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
- Hemorrhagic wound
- 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
Key Trial Info
Start Date :
June 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06135987
Start Date
June 24 2022
End Date
October 1 2024
Last Update
November 18 2023
Active Locations (1)
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1
Pr Agnès HARTEMANN
Paris, France, 75000