Clinical Research Directory

Main Inclusion Criteria: * 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. 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 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).