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 range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage Difference in PUSH Score

Timeframe: 4 weeks

Trial details

NCT IDNCT05130814

SponsorEmoled

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-07

Results submitted2024-07-31

View on ClinicalTrials.gov More Pressure Sore trials