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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 (PHOTOFINISH)

Primary Purpose

Diabetic Foot Infection

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Usual Care alone
System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
Sponsored by
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Infection focused on measuring Infected diabetic foot ulcer, Diabetic foot ulcer, DFU, Infected diabetic wound, Photodynamic therapy, PDT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San DonatoRecruiting
  • Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico MonzinoRecruiting
  • U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico GiacconeRecruiting
  • Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della MisericordiaRecruiting
  • SOS Diabetologia, Presidio Ospedaliero San JacopoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Usual Care alone

Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 4, 2022
Last Updated
December 14, 2022
Sponsor
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05613985
Brief Title
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
Acronym
PHOTOFINISH
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection
Keywords
Infected diabetic foot ulcer, Diabetic foot ulcer, DFU, Infected diabetic wound, Photodynamic therapy, PDT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Usual Care alone
Arm Type
Active Comparator
Arm Title
Arm B: system VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Usual Care alone
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
Intervention Description
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®).
Primary Outcome Measure Information:
Title
To assess the ulcer after 2 weeks of study treatment by evaluation of the following primary endpoint:
Description
Proportion of patients who had total bacterial load ≤ 1000 CFU/ml at Visit 5, measured by punch biopsy.
Time Frame
Visit 5 is the first visit of 3rd week of treatment.
Secondary Outcome Measure Information:
Title
The key secondary objective is to evaluate the ulcer after 4 weeks of study treatment by evaluation of the following endpoint:
Description
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.
Time Frame
Visit 9 is after 4 weeks of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Corti
Phone
0557361193
Ext
+39
Email
i.corti@moltenifarma.it
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Checcaglini
Phone
0557361194
Ext
+39
Email
l.checcaglini@moltenifarma.it
Facility Information:
Facility Name
U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato
City
Arezzo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessia Scatena
Email
alessia.scatena@uslsudest.toscana.it
Facility Name
Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Monami
Email
monamim@aou-careggi.toscana.it
Facility Name
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Genovese
Email
Stefano.Genovese@cardiologicomonzino.it
Facility Name
U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Giordano
Email
carla.giordano@unipa.it
Facility Name
Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiana Vermigli
Email
cristiana.vermigli@ospedale.perugia.it
Facility Name
SOS Diabetologia, Presidio Ospedaliero San Jacopo
City
Pistoia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Anichini
Email
roberto.anichini@uslcentro.toscana.it

12. IPD Sharing Statement

Learn more about this trial

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

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