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

Pressure Ulcer Clinical Trial

— PRELINEM  

Official title:

Multicenter, Long-term, Single-arm and Observational PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers (PRELINEM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763654
• Other study ID #: BA-G-H-2201
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: B. Braun Medical SA
• Contact: Aina Fernández
• Phone: +34 663 895 945
• Email: aina.fernandez[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Linovera emulsion
Apply Linovera emulsion in clinical routine

Locations

Country	Name	City	State
Spain	Hospital Alvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Number of adverse events	1 month
Secondary	Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers	Number of participants developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers	1 month