protocolSection identificationModule nctId: NCT06388603, orgStudyIdInfo id: DFORCT012023, briefTitle: RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT), acronym: DFORCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: ASST Ovest Milanese, class: OTHER, collaborators name: Hippocrates Research, collaborators name: Bonalive Biomaterials Ltd, descriptionModule briefSummary: The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.Participants will randomized into two groups:* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible., conditionsModule conditions: Osteomyelitis - Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Bioactive Glass, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: healing rate, secondaryOutcomes measure: Duration of antibiotic therapy, secondaryOutcomes measure: Rate of recurrences, secondaryOutcomes measure: Number of re-interventions because of the same lesion, secondaryOutcomes measure: Timing of re-interventions because of the same lesion, secondaryOutcomes measure: Proportion of patients undergoing amputations, secondaryOutcomes measure: Patients' Quality of Life, secondaryOutcomes measure: Patients' Quality of Life, secondaryOutcomes measure: Time back to walk, secondaryOutcomes measure: Characteristics of surgery, secondaryOutcomes measure: Length of surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone, status: NOT_YET_RECRUITING, city: Monfalcone, state: Gorizia, zip: 34074, country: Italy, contacts name: Dr. Roberto Da Ros, Med Doctor, role: CONTACT, phone: +39 3470606008, email: roberto.daros@aas2.sanita.fvg.it, contacts name: Dr. Roberto Da Ros, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.80463, lon: 13.53292, locations facility: ASST Ovest Milanese - Ospedale di Abbiategrasso, status: RECRUITING, city: Abbiategrasso, state: Milano, zip: 20081, country: Italy, contacts name: Dr. Roberto De Giglio, Med Doctor, role: CONTACT, phone: +39 331 6989775, email: roberto.degiglio@asst-ovestmi.it, contacts name: Dr. Roberto De Giglio, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Ilaria Formenti, Med Doctor, role: SUB_INVESTIGATOR, contacts name: Dr. Vincenzo Curci, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 45.39821, lon: 8.91678, locations facility: Casa di Cura Abano Terme - POLICLINICO ABANO TERME, status: NOT_YET_RECRUITING, city: Abano Terme, state: Padova, zip: 35031, country: Italy, contacts name: Dr. Christine Whisstock, Med Doctor, role: CONTACT, phone: +39 338 8924624, email: cwhisstock@casacura.it, contacts name: Dr. Christine Whisstock, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.35753, lon: 11.78725, locations facility: USL Sud Est Toscana - Ospedale San Donato, status: NOT_YET_RECRUITING, city: Arezzo, zip: 52100, country: Italy, contacts name: Dr. Alessia Scatena, Med Doctor, role: CONTACT, phone: +39 328 3281501, email: alessia.scatena@uslsudest.toscana.it, contacts name: Dr. Alessia Scatena, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Matteo Apicella, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 43.46276, lon: 11.88068, locations facility: AUSL Romagna - Ospedale Morgagni Pierantoni, status: NOT_YET_RECRUITING, city: Forlì, zip: 47121, country: Italy, contacts name: Dr. Silvia Acquati, Med Doctor, role: CONTACT, phone: +39 335 1239344, email: silvia.acquati@auslromagna.it, contacts name: Dr. Silvia Acquati, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte, status: NOT_YET_RECRUITING, city: Lucca, zip: 55100, country: Italy, contacts name: Dr. Ilaria Casadidio, Med. Doctor, role: CONTACT, phone: +39 3284882078, email: ilaria.casadidio@uslnordovest.toscana.it, contacts name: Dr. Ilaria Casadidio, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.84369, lon: 10.50447, locations facility: AOU Pisana - Ospedale di Cisanello, status: NOT_YET_RECRUITING, city: Pisa, zip: 5612, country: Italy, contacts name: Prof. Alberto Piaggesi, Med Doctor, role: CONTACT, phone: +39 3473331949, email: alberto.piaggesi@med.unipi.it, contacts name: Dr. Chiara Goretti, Med Doctor, role: CONTACT, phone: +39 3294125791, email: chiara.goretti@gmail.com, contacts name: Prof. Alberto Piaggesi, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Chiara Goretti, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False