Overview
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.
To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.
Description
Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.
This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Signed informed consent
- Patients with the possibility to participate during up 6 month follow-up.
- At least one of these criteria:
- Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
- Patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology
- Patients with medium, high or very high risk of developing a pressure ulcer following Braden Scale.
Exclusion Criteria:
- Age < 18 years
- Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- Patients in the terminal stage or receiving chemotherapy.
- Patients with more than 3 active pressure ulcers.