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.
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.
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.
Parallel
Usual Care alone
Other interventionUsual 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).
System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
DeviceSystem 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®).
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.
The key secondary objective is to evaluate the ulcer after 4 weeks of study treatment by evaluation of the following endpoint:
Proportion of patients who had a change of the target ulcer area ≥ 40% from the baseline (Visit 1) to the first follow-up visit (Visit 9) after 4 weeks of study treatment, assessed by MolecuLight i:X medical device.
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