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