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EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

NCT05130814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-28

Study results available
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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.

Conditions

  • Pressure Sore
  • Pressure Ulcer
  • Pressure Ulcers Stage III
  • Pressure Ulcers Stage II

Interventions

DEVICE

blue light photobiomodulation

1 minute irradiation of blue light performed with EmoLED device.

PROCEDURE

cleansing

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

COMBINATION_PRODUCT

hyaluronic acid gauze plus polyurethane foam

every 48 hours or as needed

DRUG

zinc cream or hyaluronic acid sodium salt + metallic silver

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

PROCEDURE

topical treatment

topical treatment indicated for that stage of the lesion

PROCEDURE

bandage

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"

Sponsors & Collaborators

  • Emoled

    lead INDUSTRY

Principal Investigators

  • Stefano Gasperini · Medical Advisor

  • Claudio Macchi · IRCCS Don Carlo Gnocchi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-03-07
Completion
2024-03-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130814 on ClinicalTrials.gov