Diabetic Foot InfectionPHOTOFINISHNCT05613985
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
A study of Diabetic Foot Infection, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 7 sitesItaly
- Study dates
- 14 Sep 2021to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato
Arezzo
Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi
Florence
Centro di Assistenza Vulnologica, Ospedale Villa Scassi
Genova, Genova, 16149
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino
Milan, Milano, 20138
U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone
Palermo
Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia
Perugia
SOS Diabetologia, Presidio Ospedaliero San Jacopo
Pistoia
About this study
Official 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.
Read the detailed description
This study evaluates 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.
Eligible patients are randomised in a 1:1 ratio to receive Usual Care and the system VULNOFAST® plus / VULNOLIGHT®, or Usual Care alone according the following scheme:
- Arm A: Usual Care alone: 2 times a week (4 treatment weeks, 8 treatments).
- Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care: both treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®).
The Treatment period will be followed by a Follow up period: the study will last up to 57 days for each patient, including the screening period. Thirteen study visits are planned starting from the screening and including Treatment and Follow up periods.
All patients enrolled in this study:
- are administered with amoxicillin and clavulanic acid treatment (as background antibiotic therapy) from Visit 1 until receipt of the antibiogram. Upon receipt of the antibiogram, the Investigator decides whether or not to continue the background therapy or to treat the patient with a different antibiotic treatment, according the clinical practice in the site.
- use an appropriate off-loading system from Visit 1 to Visit 12
The primary objective is to assess clinical improvement 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 (Visit 5 is the first visit of 3rd week of treatment), measured by punch biopsy.
The key secondary objective is also to assess clinical improvement after 4 weeks of study treatment reflected by the key secondary endpoint:
- proportion of patients who had a reduction 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.
Further secondary objectives are evaluated in the study, and a pharmacoeconomic analysis is foreseen.
- Conditions
- Diabetic Foot Infection
- Being tested
- Usual Care alone, System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
- Keywords
- Infected diabetic foot ulcer, Diabetic foot ulcer, DFU, Infected diabetic wound, Photodynamic therapy, PDT
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care aloneOther
Usual Care is defined as the following procedures to apply to the foot ulcer, carried out in the order in which they are listed:
Sharp debridement (the debridement will be performed only if non-vital tissue is present), Mild washing of the whole ulcer with physiological solution, Treatment with topical antiseptic containing Iodopovidone, Covering with iodopovidone impregnated gauze while the ulcer is clinically infected (PEDIS ≥ 2) [If, during the study, PEDIS is < 2, the ulcer will be covered with nonadherent paraffin gauze].
Treatment 2 times a week (4 treatment weeks, 8 treatments).
System VULNOFAST® plus / VULNOLIGHT® in addition to Usual CareDevice
System VULNOFAST® plus / VULNOLIGHT®: VULNOFAST® plus sterile solution, in combination with a red light source VULNOLIGHT®. VULNOFAST® plus and VULNOLIGHT® will be used in accordance with their Instructions for Use (IFU) and User Manual.
Treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Usual Care alone | Active comparator | Not described Receives: Other: Usual Care alone |
| Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care | Experimental | Not described Receives: Device: System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 5 is the first visit of 3rd week of treatment.
Secondary outcomes (1)
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.
Measured: Visit 9 is after 4 weeks of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Sep 2021
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomised, two arms study to evaluate the efficacy and safety of topical application of the system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care, versus the Usual Care alone.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613985
- Sponsor's protocol ID
- MOLT-2019-01
- Acronym
- PHOTOFINISH
- Status last verified
- Nov 2026
- First submitted
- 4 Nov 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05613985
- Acronym / sponsor ID
- PHOTOFINISH / MOLT-2019-01
- Conditions
- Diabetic Foot Infection
- Keywords
- Infected diabetic foot ulcer, Diabetic foot ulcer, DFU, Infected diabetic wound, Photodynamic therapy, PDT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates 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.
Eligible patients are randomised in a 1:1 ratio to receive Usual Care and the system VULNOFAST® plus / VULNOLIGHT®, or Usual Care alone according the following scheme:
- Arm A: Usual Care alone: 2 times a week (4 treatment weeks, 8 treatments).
- Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care: both treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®).
The Treatment period will be followed by a Follow up period: the study will last up to 57 days for each patient, including the screening period. Thirteen study visits are planned starting from the screening and including Treatment and Follow up periods.
All patients enrolled in this study:
- are administered with amoxicillin and clavulanic acid treatment (as background antibiotic therapy) from Visit 1 until receipt of the antibiogram. Upon receipt of the antibiogram, the Investigator decides whether or not to continue the background therapy or to treat the patient with a different antibiotic treatment, according the clinical practice in the site.
- use an appropriate off-loading system from Visit 1 to Visit 12
The primary objective is to assess clinical improvement 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 (Visit 5 is the first visit of 3rd week of treatment), measured by punch biopsy.
The key secondary objective is also to assess clinical improvement after 4 weeks of study treatment reflected by the key secondary endpoint:
- proportion of patients who had a reduction 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.
Further secondary objectives are evaluated in the study, and a pharmacoeconomic analysis is foreseen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomised, two arms study to evaluate the efficacy and safety of topical application of the system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care, versus the Usual Care alone.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Usual Care alone | Active comparator | Other: Usual Care alone |
| Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care | Experimental | Device: System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care aloneUsual Care is defined as the following procedures to apply to the foot ulcer, carried out in the order in which they are listed: Sharp debridement (the debridement will be performed only if non-vital tissue is present), Mild washing of the whole ulcer with physiological solution, Treatment with topical antiseptic containing Iodopovidone, Covering with iodopovidone impregnated gauze while the ulcer is clinically infected (PEDIS ≥ 2) [If, during the study, PEDIS is < 2, the ulcer will be covered with nonadherent paraffin gauze]. Treatment 2 times a week (4 treatment weeks, 8 treatments). | Other | Arm A: Usual Care alone |
| System VULNOFAST® plus / VULNOLIGHT® in addition to Usual CareSystem VULNOFAST® plus / VULNOLIGHT®: VULNOFAST® plus sterile solution, in combination with a red light source VULNOLIGHT®. VULNOFAST® plus and VULNOLIGHT® will be used in accordance with their Instructions for Use (IFU) and User Manual. Treatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus / VULNOLIGHT®). | Device | Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care |
Primary outcome
To assess the ulcer after 2 weeks of study treatment by evaluation of the following primary endpoint:
Time frame: Visit 5 is the first visit of 3rd week of treatment.
Proportion of patients who had total bacterial load ≤ 1000 CFU/ml at Visit 5, measured by punch biopsy.
1 secondary outcome
The key secondary objective is to evaluate the ulcer after 4 weeks of study treatment by evaluation of the following endpoint:
Time frame: Visit 9 is after 4 weeks of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Foot Infection, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the ulcer after 2 weeks of study treatment by evaluation of the following primary endpoint: (time frame: Visit 5 is the first visit of 3rd week of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.