EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers (NCT05130814) | Clinical Trial Compass
CompletedNot Applicable
EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers
Italy48 participantsStarted 2021-12-01
Plain-language summary
The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage decubitus lesion, comparing this method with the effectiveness of the therapy commonly used in the clinical field.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with 2Ā° or 3Ā° stage lower limb/ sacrum located pressure ulcers;
* Patients with 2Ā° or 3Ā° stage pressure ulcers with a ā„ 2cmĀ² lesion area;
* Patients with a hospitalization waiting time \< 30 day;
* Men and women aged ā„ 50 years;
* Patients with a Braden scale score ā„ 11;
Exclusion Criteria:
* Patients who are participating in other clinical trials with drug or medical device;
* Patients with third stage pressure lesions, on the lower limbs or on the sacrum, with undermining wounds, tunneling or eschar;
* Patients with systemic or superficial infection at the time of recruitment, that need systemic antibiotic therapy;
* Patients with a history of self-harm who can voluntarily alter the course of healing;
* Patients under intravenous therapy with doses of corticosteroids above 40mg/day;
* Patients under immunosuppressant or cytostatic drugs therapy;
* Women who are pregnant or breastfeeding1;
* Patients with neoplasia;
* Patients with pathologies that induce skin photosensitivity;
* Patients with a life expectancy of less than 30 days.