PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU (PRELINEM)

B. Braun

Status

Enrolling

Conditions

Pressure Ulcer

Treatments

Device: Linovera emulsion

Study type

Observational

Funder types

Industry

Identifiers

NCT05763654

BA-G-H-2201

Details and patient eligibility

About

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.

Full 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).

Enrollment

164 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.