Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

NATerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 22, 2022

Primary Completion Date

March 6, 2024

Study Completion Date

March 6, 2024

Conditions
UlcerAcral NevusSclerodermaDigital Ulcer
Interventions
DEVICE

EmoLED treatment

Treatment with the EmoLED device consists of irradiating each area of 5 cm in diameter of the lesion for 60 seconds; if the lesion is larger than 5 cm in diameter, the applications will be repeated up to cover the entire area of interest. EmoLED treatment is additional to the standard therapy for the patient.

PROCEDURE

current Standard of Care

The acral lesions will be cleansed with physiological solution, disinfected with a special device and, if necessary, a debridement will be carried out with the most appropriate method.

Trial Locations (1)

50134

AOU Careggi - SOD Reumatologia - Scleroderma Unit, Florence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Emoled

INDUSTRY

NCT05181644 - Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma. | Biotech Hunter | Biotech Hunter