EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emoled
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• Patients with 2° or 3° stage lower limb/ sacrum located pressure ulcers;

• Patients with 2° or 3° stage pressure ulcers with a ≥ 2cm² lesion area;

• Patients with a hospitalization waiting time < 30 day;

• Men and women aged ≥ 50 years;

• Patients with a Braden scale score ≥ 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.