Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

Launched by LABORATOIRES URGO · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying the safety and effectiveness of three specific types of dressings—UrgoStart Plus® Border, UrgoStart Plus® Pad, and UrgoStart Interface®—in treating chronic wounds like diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) in real-life settings in France. The goal is to see how well these dressings work and how they can improve the quality of life for patients over a 12-week period.

To participate in this study, you need to be an adult outpatient who has signed consent and has either a venous leg ulcer or a diabetic foot ulcer. You should also be able to use one of the three dressings mentioned and complete a self-questionnaire. However, certain conditions would exclude you from joining, such as having an infected wound or being pregnant. If you qualify, you can expect to be monitored by a healthcare provider for 12 weeks as part of the trial. This study aims to provide valuable insights into how these dressings perform in everyday medical care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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