CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
hyaluronic acid gauze plus polyurethane foam +5 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05130814
NCT05130814N/ACompleted

Perspective Randomized Study Aimed at Evaluating the Effectiveness of the EmoLED Medical Device in the Treatment of Second and Third Stage Pressure Ulcers

Emoled·interventional·Posted Nov 23, 2021·Updated Jan 28, 2025

In Brief

A clinical study evaluating blue light photobiomodulation, cleansing, and 4 other interventions for Pressure Sore and 3 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 23, 2021
Enrollment StartDec 1, 2021
Primary CompletionMar 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.6 years ago

Interventions

blue light photobiomodulationdevice

1 minute irradiation of blue light performed with EmoLED device.

cleansingprocedure

cleaning of the wound area with saline or ringer's lactate

hyaluronic acid gauze plus polyurethane foamcombination

every 48 hours or as needed

zinc cream or hyaluronic acid sodium salt + metallic silverdrug

applied to prevent and/or treat the skin maceration of the surrounding area

topical treatmentprocedure

topical treatment indicated for that stage of the lesion

bandageprocedure

it consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"