NCT05613985 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
| NCT ID | NCT05613985 |
| Status | Recruiting |
| Phase | — |
| Sponsor | L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. |
| Condition | Diabetic Foot Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2021-09-14 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2021-09-14 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05613985 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05613985 currently recruiting?
Yes, NCT05613985 is actively recruiting participants. Contact the research team at i.corti@moltenifarma.it for enrollment information.
Where is the NCT05613985 trial being conducted?
This trial is being conducted at Arezzo, Italy, Florence, Italy, Genova, Italy, Milan, Italy and 3 additional locations.
Who is sponsoring the NCT05613985 clinical trial?
NCT05613985 is sponsored by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.. The trial plans to enroll 78 participants.