PMCF Study on the Safety of Linovera Emulsion for the Pre... | NCT05763654

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

NCT05763654

Sponsor

B. Braun Medical SA

Status

Unknown status

Last Update Posted

Oct 23, 2023Actual

Enrollment

164Estimated

Phase

Not provided

Conditions

Pressure Ulcer

Interventions

Linovera emulsion

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Nov 25, 2022

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2023

Last Update Posted Date

Oct 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Linovera emulsion		No intervention. Routine clinical practice.	Device: Linovera emulsion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linovera emulsion	Device	Apply Linovera emulsion in clinical routine	Linovera emulsion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers	Number of participants developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Already described in Inclusion and Exclusion criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aina Fernández	Contact	+34 663 895 945		aina.fernandez@bbraun.com
Joan Lluís Pérez, Ing	Contact	+34 670 528 799		joan_lluis.perez@bbraun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Alvaro Cunqueiro	Recruiting	Vigo		36312	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided