Leg Ulcers Standards of Care Enhancement

NACompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

May 14, 2019

Primary Completion Date

February 29, 2024

Study Completion Date

February 29, 2024

Conditions
Venous Leg UlcerMixed Leg Ulcer
Interventions
DEVICE

EmoLED

The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.

PROCEDURE

current Standards Of Care

"The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.~Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out."

Trial Locations (5)

24025

Ospedale Briolini, ASST Bergamo EST, Gazzaniga

36061

Geriatrics Unit, Presidio Ospedaliero di Rete San Bassiano, ULSS 7 Pedemontana, Bassano del Grappa

40138

Dermatology Unit AOU Policlinico Sant'Orsola - Malpighi, Bologna

56025

Ospedale Felice Lotti, Pontedera

56126

Dermatology Unit, Azienda Ospedaliero Universitaria Pisana, Stabilimento di S. Chiara, Pisa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Emoled

INDUSTRY

NCT04689009 - Leg Ulcers Standards of Care Enhancement | Biotech Hunter | Biotech Hunter