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

Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study

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 (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

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 carried out in France, in accordance with national and European regulations (RDM 2017/745).

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