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

Overview

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.

This study evaluates 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. Eligible patients are randomised in a 1:1 ratio to receive Usual Care and the system VULNOFAST® plus / VULNOLIGHT®, or Usual Care alone according the following scheme: * Arm A: Usual Care alone: 2 times a week (4 treatment weeks, 8 treatments). * Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care: both treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®). The Treatment period will be followed by a Follow up period: the study will last up to 57 days for each patient, including the screening period. Thirteen study visits are planned starting from the screening and including Treatment and Follow up periods. All patients enrolled in this study: * are administered with amoxicillin and clavulanic acid treatment (as background antibiotic therapy) from Visit 1 until receipt of the antibiogram. Upon receipt of the antibiogram, the Investigator decides whether or not to continue the background therapy or to treat the patient with a different antibiotic treatment, according the clinical practice in the site. * use an appropriate off-loading system from Visit 1 to Visit 12 The primary objective is to assess clinical improvement 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 (Visit 5 is the first visit of 3rd week of treatment), measured by punch biopsy. The key secondary objective is also to assess clinical improvement after 4 weeks of study treatment reflected by the key secondary endpoint: \- proportion of patients who had a reduction 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. Further secondary objectives are evaluated in the study, and a pharmacoeconomic analysis is foreseen.