Evaluating a new treatment for infected diabetic foot ulcers

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)

This study is testing if a new treatment for infected diabetic foot ulcers, used with regular care, can help people heal better than just using regular care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. (Industry-sponsored)
• Locations: 7 sites (Arezzo and 6 other locations)
• Trial ID: NCT05613985 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness and safety of the VULNOFAST® plus/VULNOLIGHT® system in combination with usual care compared to usual care alone for treating infected diabetic foot ulcers. Participants will be randomly assigned to receive either the new treatment alongside standard care or standard care alone over a treatment period of four weeks. The study will monitor clinical improvement after two weeks and will include a follow-up period of up to 57 days. All patients will also receive background antibiotic therapy and an off-loading system to support healing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with type 1 or type 2 diabetes and chronic diabetic foot ulcers that meet specific size and depth criteria.

Not a fit: Patients with diabetic foot ulcers that do not meet the study's size or depth criteria, or those with uncontrolled diabetes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with infected diabetic foot ulcers.

How similar studies have performed: While this approach is innovative, similar studies using photodynamic therapy have shown promise in treating chronic wounds.

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).

Where this trial is running

Arezzo and 6 other locations

• U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato — Arezzo, Italy (Recruiting)
• Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (Recruiting)
• Centro di Assistenza Vulnologica, Ospedale Villa Scassi — Genova, Italy (Recruiting)
• Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino — Milan, Italy (Recruiting)
• U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone — Palermo, Italy (Recruiting)
• Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia — Perugia, Italy (Recruiting)
• SOS Diabetologia, Presidio Ospedaliero San Jacopo — Pistoia, Italy (Recruiting)

Study contacts

• Study coordinator: Ilaria Corti

Conditions Diabetic Foot Infection; Infected diabetic foot ulcer; Diabetic foot ulcer; DFU; Infected diabetic wound; Photodynamic therapy; PDT