PRELINEM: PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers

• Sponsor: B. Braun Medical SA (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05763654
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer; Pressure Injury; Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)	Device: Linovera emulsion

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 164 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Linovera emulsion No intervention. Routine clinical practice.	Device: Linovera emulsion; Apply Linovera emulsion in clinical routine

Outcome Measures

Primary Outcome Measures

1. Number of adverse events [1 month]

   Number of adverse events

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Alvaro Cunqueiro	Vigo		Spain	36312

Sponsors and Collaborators

• B. Braun Medical SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: B. Braun Medical SA
• ClinicalTrials.gov Identifier: NCT05763654
• Other Study ID Numbers: BA-G-H-2201
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Pressure Ulcer; Ulcer; Crush Injuries

Study Results

No Results Posted as of Mar 10, 2023