Diabetic Foot Infection Clinical Trial
— PHOTOFINISHOfficial title:
A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus / VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH)
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.
Status | Recruiting |
Enrollment | 146 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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). |
Country | Name | City | State |
---|---|---|---|
Italy | U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato | Arezzo | |
Italy | Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | Centro di Assistenza Vulnologica, Ospedale Villa Scassi | Genova | |
Italy | Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino | Milano | |
Italy | U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone | Palermo | |
Italy | Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia | Perugia | |
Italy | SOS Diabetologia, Presidio Ospedaliero San Jacopo | Pistoia |
Lead Sponsor | Collaborator |
---|---|
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the ulcer 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, measured by punch biopsy. | Visit 5 is the first visit of 3rd week of treatment. | |
Secondary | The key secondary objective is to evaluate the ulcer after 4 weeks of study treatment by evaluation of the following endpoint: | Proportion of patients who had a change 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. | Visit 9 is after 4 weeks of study treatment |
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