78
Participants
Start Date
September 14, 2021
Primary Completion Date
February 28, 2026
Study Completion Date
June 30, 2026
Usual Care alone
"Usual Care is defined as the following procedures to apply to the foot ulcer, carried out in the order in which they are listed:~Sharp debridement (the debridement will be performed only if non-vital tissue is present), Mild washing of the whole ulcer with physiological solution, Treatment with topical antiseptic containing Iodopovidone, Covering with iodopovidone impregnated gauze while the ulcer is clinically infected (PEDIS ≥ 2) \[If, during the study, PEDIS is \< 2, the ulcer will be covered with nonadherent paraffin gauze\].~Treatment 2 times a week (4 treatment weeks, 8 treatments)."
System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
"System VULNOFAST® plus / VULNOLIGHT®: VULNOFAST® plus sterile solution, in combination with a red light source VULNOLIGHT®. VULNOFAST® plus and VULNOLIGHT® will be used in accordance with their Instructions for Use (IFU) and User Manual.~Treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®)."
RECRUITING
Centro di Assistenza Vulnologica, Ospedale Villa Scassi, Genova
RECRUITING
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino, Milan
RECRUITING
U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato, Arezzo
RECRUITING
Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi, Florence
RECRUITING
U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone, Palermo
RECRUITING
Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia, Perugia
RECRUITING
SOS Diabetologia, Presidio Ospedaliero San Jacopo, Pistoia
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
INDUSTRY