NCT05763654

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
• Phase: —
• Study type: Observational
• Enrollment: 164 (estimated)
• Sponsor: B. Braun Medical SA · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Linovera emulsion	Apply Linovera emulsion in clinical routine

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-03-10
• Last updated: 2023-10-23

Locations

1 site across 1 country: Spain