RecruitingNot ApplicableNCT05613985

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

A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus / VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH)


Sponsor

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

Enrollment

78 participants

Start Date

Sep 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment with Usual Care alone, for the healing of chronic diabetic foot ulcer. VULNOFAST® plus is a sterile solution used in combination with a red light source VULNOLIGHT®. Usual Care is defined as procedures to apply to the foot ulcer, carried out in the order in which they are listed in the protocol.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care and Usual Care alone for people with diabetic foot infection. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUsual 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).

DEVICESystem 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®).


Locations(7)

U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato

Arezzo, Italy

Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Centro di Assistenza Vulnologica, Ospedale Villa Scassi

Genova, Italy

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

Milan, Italy

U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone

Palermo, Italy

Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia

Perugia, Italy

SOS Diabetologia, Presidio Ospedaliero San Jacopo

Pistoia, Italy

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NCT05613985


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