Condition: Osteomyelitis - Foot · Sponsor: ASST Ovest Milanese
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.
This description comes directly from the study's public registry record.
Dr. Roberto De Giglio, Med Doctor · +39 331 6989775 · roberto.degiglio@asst-ovestmi.it
Always discuss trial participation with your own doctor first.
| ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone | Monfalcone, Gorizia, Italy | Not Yet Recruiting |
| ASST Ovest Milanese - Ospedale di Abbiategrasso | Abbiategrasso, Milano, Italy | Recruiting |
| Casa di Cura Abano Terme - POLICLINICO ABANO TERME | Abano Terme, Padova, Italy | Not Yet Recruiting |
| USL Sud Est Toscana - Ospedale San Donato | Arezzo, Italy | Not Yet Recruiting |
| AUSL Romagna - Ospedale Morgagni Pierantoni | Forlì, Italy | Not Yet Recruiting |
| Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte | Lucca, Italy | Not Yet Recruiting |
| AOU Pisana - Ospedale di Cisanello | Pisa, Italy | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06388603