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 (PHOTOFINISH)
Diabetic Foot Infection
About this trial
This is an interventional treatment trial for Diabetic Foot Infection focused on measuring Infected diabetic foot ulcer, Diabetic foot ulcer, DFU, Infected diabetic wound, Photodynamic therapy, PDT
Eligibility Criteria
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).
Sites / Locations
- U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San DonatoRecruiting
- Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria CareggiRecruiting
- Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico MonzinoRecruiting
- U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico GiacconeRecruiting
- Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della MisericordiaRecruiting
- SOS Diabetologia, Presidio Ospedaliero San JacopoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A: Usual Care alone
Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care