PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascul… (NCT05763654) | Clinical Trial Compass
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PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
Spain164 participantsStarted 2022-12-15
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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.