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

NCT05613985 | Recruiting

• 1 other identifier: MOLT-2019-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Diabetic Foot Infection

Keywords

Infected diabetic foot ulcer; Diabetic foot ulcer; DFU; Infected diabetic wound; Photodynamic therapy; PDT

Outcome Measures

Primary Outcomes (1)

• To assess the ulcer after 2 weeks of study treatment by evaluation of the following primary endpoint:

  Proportion of patients who had total bacterial load ≤ 1000 CFU/ml at Visit 5, measured by punch biopsy.

  Visit 5 is the first visit of 3rd week of treatment.

Secondary Outcomes (1)

• The key secondary objective is to evaluate the ulcer after 4 weeks of study treatment by evaluation of the following endpoint:

  Visit 9 is after 4 weeks of study treatment

Study Arms (2)

Arm A: Usual Care alone

ACTIVE COMPARATOR

Other: Usual Care alone

Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care

EXPERIMENTAL

Device: System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care

Interventions

Usual Care alone OTHER

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).

Arm A: Usual Care alone

System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care DEVICE

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®).

Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give voluntary written informed consent. The ICF, must be signed before any study-related procedures and/or assessments are performed.
• Outpatients or inpatients (male and female) of any ethnic origin, aged 18 years or over, diagnosed with type 1 or type 2 diabetes mellitus.
• Glycaemic control confirmed by a glycated haemoglobin (HbA1c) levels ≤10% (86 mmol/mol), evaluated in the 3 months before enrolment or at Visit 1.
• Fasting plasma glucose (FPG) less than 300 mg/dl.
• A chronic diabetic foot ulcer (DFU) below the malleolus, with an area ≥ 2 and ≤ 40 cm2 and with a maximum diameter/length ≤ 10 cm measured by MolecuLight i:X medical device \[note: chronic wound is defined as a wound that, after the normal clinical practice, does not start healing within 4 weeks or does not heal within 8 weeks\].
• A diabetic foot wound with a depth equal or higher to grade 2 according to the category "Depth/tissue loss" of PEDIS, but not involving bone, diagnosed by clinical examination.
• Presence of infected foot ulcer of grade 2 according to the category "Infection" of PEDIS, diagnosed by clinical examination.
• Able to take oral medications.
• Patients must be willing and able to comply with the protocol and study procedures.

You may not qualify if:

• Patients unable to give written informed consent.
• Females who are pregnant or lactating.
• Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
• Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to Visit 1.
• Ankle brachial systolic blood pressure index \< 0.5 (Winsor Index) in the infected limb.
• Ulcer probe to bone positive.
• Any surgery planned during the study period (from ICF signature to last planned follow-up visit).
• Clinical diagnosis of peripheral vascular disease (PVD) requiring percutaneous or surgical revascularization.
• Transcutaneous oximetry (TcPo2) measurement \< 30 mmHg.
• Use of any antibiotics (local or systemic) within 48h before Visit 1.
• Patient for whom punch biopsy is contraindicated.
• Patients that cannot take amoxicillin and clavulanic acid (background antibiotic therapy) at the dosage stated in the protocol and according to the current Summary of Product Characteristics (SPC).
• Patients that cannot be treated with topical antiseptic containing Iodopovidone and/or with iodopovidone impregnated gauze according to the contraindication available in the current Summary of Product Characteristics (SPC).

Sponsors & Collaborators

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

Study Sites (7)

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

Arezzo, Italy

RECRUITING

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

Florence, Italy

RECRUITING

Centro di Assistenza Vulnologica, Ospedale Villa Scassi

Genova, 16149, Italy

RECRUITING

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

Milan, 20138, Italy

RECRUITING

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

Palermo, Italy

RECRUITING

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

Perugia, Italy

RECRUITING

SOS Diabetologia, Presidio Ospedaliero San Jacopo

Pistoia, Italy

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Ilaria Corti

CONTACT

0557361193; i.corti@moltenifarma.it

Laura Checcaglini

CONTACT

0557361194; l.checcaglini@moltenifarma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomised, two arms study to evaluate the efficacy and safety of topical application of the system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care, versus the Usual Care alone.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: September 14, 2021
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IT (7)