Actively Recruiting
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
Led by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. · Updated on 2025-08-08
78
Participants Needed
7
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent before any study procedures
- Male or female patients aged 18 years or older with type 1 or type 2 diabetes
- Glycated hemoglobin (HbA1c) 10% or less within 3 months before enrollment or at Visit 1
- Fasting plasma glucose less than 300 mg/dl
- Chronic diabetic foot ulcer below the ankle, 2 to 40 cm² in area, with maximum length 10 cm
- Diabetic foot wound with depth grade 2 or higher by PEDIS, not involving bone
- Infected foot ulcer of grade 2 by PEDIS
- Able to take oral medications
- Willing and able to comply with study procedures
You will not qualify if you...
- Unable to give written informed consent
- Pregnant or lactating females
- Females of childbearing potential not using adequate contraception
- Participation in another clinical trial or use of investigational products within 30 days prior to Visit 1
- Ankle brachial systolic pressure index less than 0.5 in the infected limb
- Ulcer with probe to bone positive
- Planned surgery during the study period
- Peripheral vascular disease requiring revascularization
- Transcutaneous oximetry less than 30 mmHg
- Use of any antibiotics within 48 hours before Visit 1
- Contraindication to punch biopsy
- Unable to take amoxicillin and clavulanic acid as per protocol
- Unable to use iodopovidone antiseptic or iodopovidone gauze per contraindications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato
Arezzo, Italy
Actively Recruiting
2
Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Actively Recruiting
3
Centro di Assistenza Vulnologica, Ospedale Villa Scassi
Genova, Italy, 16149
Actively Recruiting
4
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino
Milan, Italy, 20138
Actively Recruiting
5
U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone
Palermo, Italy
Actively Recruiting
6
Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia
Perugia, Italy
Actively Recruiting
7
SOS Diabetologia, Presidio Ospedaliero San Jacopo
Pistoia, Italy
Actively Recruiting
Research Team
I
Ilaria Corti
CONTACT
L
Laura Checcaglini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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