PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
PRELINEM
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)
1 other identifier
observational
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 23, 2023
October 1, 2023
12 months
November 25, 2022
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of adverse events
Number of adverse events
1 month
Secondary Outcomes (1)
Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers
1 month
Study Arms (1)
Linovera emulsion
No intervention. Routine clinical practice.
Interventions
Eligibility Criteria
Already described in Inclusion and Exclusion criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Alvaro Cunqueiro
Vigo, 36312, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2022
First Posted
March 10, 2023
Study Start
December 15, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
October 23, 2023
Record last verified: 2023-10