Assessing the safety of Linovera Emulsion for preventing pressure ulcers and diabetic foot ulcers
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)
This study is testing if Linovera Emulsion can safely help adults at risk of developing pressure ulcers and diabetic foot ulcers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | B. Braun Medical SA Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vigo) |
| Trial ID | NCT05763654 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of Linovera® Emulsion in preventing Grade I pressure ulcers, vascular ulcers, and diabetic foot ulcers. It involves a proactive Post Market Clinical Follow-up (PMCF) to gather diverse safety and performance data over a six-month follow-up period. Eligible participants include adults at medium to very high risk of developing these conditions, with assessments based on various clinical parameters.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are at medium to very high risk of developing pressure ulcers or diabetic foot ulcers.
Not a fit: Patients under 18, those with known allergies to Linovera Emulsion, or those in terminal stages of illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of developing pressure ulcers and diabetic foot ulcers.
How similar studies have performed: Other studies have shown promising results with similar preventive approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vigo
- Hospital Alvaro Cunqueiro — Vigo, Spain (Recruiting)
Study contacts
- Study coordinator: Aina Fernández
- Email: aina.fernandez@bbraun.com
- Phone: +34 663 895 945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.