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
Recruiting now · Not applicable
Conditions studied: Diabetic Foot Infection
In brief
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.
Key facts
- Study ID
- NCT05613985
- Run by
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
- People needed
- 78
- Starts
- 2021-09-14
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato — Arezzo, Italy (enrolling)
- Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (enrolling)
- Centro di Assistenza Vulnologica, Ospedale Villa Scassi — Genova, Italy (enrolling)
- Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino — Milan, Italy (enrolling)
- U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone — Palermo, Italy (enrolling)
- Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia — Perugia, Italy (enrolling)
- SOS Diabetologia, Presidio Ospedaliero San Jacopo — Pistoia, Italy (enrolling)
Full record on ClinicalTrials.gov
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