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

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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.

Trial design

164 participants in 1 patient group

Linovera emulsion
Description:
No intervention. Routine clinical practice.
Treatment:
Device: Linovera emulsion

Trial contacts and locations

1

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Central trial contact

Aina Fernández; Joan Lluís Pérez, Ing

Data sourced from clinicaltrials.gov

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