EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

March 7, 2024

Study Completion Date

March 7, 2024

Conditions
Pressure SorePressure UlcerPressure Ulcers Stage IIIPressure 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"

Trial Locations (1)

50143

IRCCS Don Carlo Gnocchi, Florence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Emoled

INDUSTRY

NCT05130814 - EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers | Biotech Hunter | Biotech Hunter