PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers

NARecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

February 28, 2026

Study Completion Date

June 30, 2026

Conditions
Diabetic Foot Infection
Interventions
OTHER

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)."

DEVICE

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®)."

Trial Locations (7)

16149

RECRUITING

Centro di Assistenza Vulnologica, Ospedale Villa Scassi, Genova

20138

RECRUITING

Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino, Milan

Unknown

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

All Listed Sponsors
lead

L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

INDUSTRY

NCT05613985 - PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter