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

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05763654

Acronym

PRELINEM

Enrollment

164

Registered

2023-03-10

Start date

2022-12-15

Completion date

2023-12-31

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

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).

Interventions

DEVICELinovera emulsion

Apply Linovera emulsion in clinical routine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse events	1 month	Number of adverse events

Secondary

Measure	Time frame	Description
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

Countries

Spain

Contacts

Primary ContactAina Fernández

aina.fernandez@bbraun.com+34 663 895 945

Backup ContactJoan Lluís Pérez, Ing

joan_lluis.perez@bbraun.com+34 670 528 799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026