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

Launched by L.MOLTENI & C. DEI F.LLI ALITTI-SOC. DI ESERCIZIO S.P.A. · Nov 4, 2022

Keywords

ClinConnect Summary

The PHOTOFINISH clinical trial is studying a new treatment method for infected diabetic foot ulcers. Researchers want to find out if adding a special system called VULNOFAST® Plus, which includes a sterile solution and a red light source (VULNOLIGHT®), can help heal these wounds better than the usual care alone. The usual care involves standard procedures for treating foot ulcers, and this trial aims to see if the new treatment improves healing times and outcomes.

To participate in this trial, you need to be at least 18 years old and diagnosed with type 1 or type 2 diabetes. You should have a chronic diabetic foot ulcer that hasn’t started healing after four weeks or hasn’t healed within eight weeks. Other important criteria include having controlled blood sugar levels and being able to take oral medications. If you join the study, you can expect to receive either the new treatment alongside the usual care or just the usual care alone, while the researchers monitor your progress. This trial is currently open for participants, and it aims to provide valuable insights into better healing options for diabetic foot infections.

Gender

ALL

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).