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

Summary

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.

Eligibility

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).

Conditions2

Browse More Trials