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

Main Inclusion Criteria:

• Able and willing to give voluntary written informed consent. The ICF, must be signedbefore any study-related procedures and/or assessments are performed.

• Outpatients or inpatients (male and female) of any ethnic origin, aged 18 years orover, diagnosed with type 1 or type 2 diabetes mellitus.

• Glycaemic control confirmed by a glycated haemoglobin (HbA1c) levels ≤10% (86mmol/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 ≤ 40cm2 and with a maximum diameter/length ≤ 10 cm measured by MolecuLight i:X medicaldevice [note: chronic wound is defined as a wound that, after the normal clinicalpractice, 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 thecategory "Depth/tissue loss" of PEDIS, but not involving bone, diagnosed by clinicalexamination.

• Presence of infected foot ulcer of grade 2 according to the category "Infection" ofPEDIS, diagnosed by clinical examination.

• Able to take oral medications.

• Patients must be willing and able to comply with the protocol and study procedures.

Main Exclusion Criteria:

• Patients unable to give written informed consent.

• Females who are pregnant or lactating.

• Females who are of child bearing potential and not taking adequate contraceptiveprecautions are excluded from the trial. Females of child bearing potential takingacceptable contraceptive precautions can be included.

• Participation in any other clinical trial or currently receiving any otherinvestigational product(s) within 30 days prior to Visit 1.

• Ankle brachial systolic blood pressure index < 0.5 (Winsor Index) in the infectedlimb.

• Ulcer probe to bone positive.

• Any surgery planned during the study period (from ICF signature to last plannedfollow-up visit).

• Clinical diagnosis of peripheral vascular disease (PVD) requiring percutaneous orsurgical 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 antibiotictherapy) at the dosage stated in the protocol and according to the current Summaryof Product Characteristics (SPC).

• Patients that cannot be treated with topical antiseptic containing Iodopovidoneand/or with iodopovidone impregnated gauze according to the contraindicationavailable in the current Summary of Product Characteristics (SPC).