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

Recruiting

• Conditions: Pressure Ulcer
• Interventions: Device: Linovera emulsion

• Registration Number: NCT05763654
• Lead Sponsor: B. Braun Medical SA

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-11-25
• Study Start: 2022-12-15
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Linovera emulsion	Linovera emulsion	No intervention. Routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	1 month	Number of adverse events

Secondary Outcome Measures

Name	Time	Method
Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers	1 month	Number of participants developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers

Trial Locations

Locations (1)

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain