RecruitingNot ApplicableNCT06388603

RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)

A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot


Sponsor

ASST Ovest Milanese

Enrollment

140 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Bioactive Glass and Standard of Care for people with osteomyelitis - foot. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioactive Glass

Bonalive Granules and Bonalive Putty will be used (according to their IFU and CE certification) to fill the bone void after the debridment of infected tissue as they have osteoconductive and osteostimulative properties that allow bone rigeneration. Moreover, Bonalive Granules also present some bacteria growth inhibiting properties to combact bone infection propoer of Ostemyelitis.

OTHERStandard of Care

The investigators are left free to proceed according to the normal standar procedure they normally use. The procedures can vary according to investigator judgment also depending on the state of Osteomylitis.


Locations(7)

ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone

Monfalcone, Gorizia, Italy

ASST Ovest Milanese - Ospedale di Abbiategrasso

Abbiategrasso, Milano, Italy

Casa di Cura Abano Terme - POLICLINICO ABANO TERME

Abano Terme, Padova, Italy

USL Sud Est Toscana - Ospedale San Donato

Arezzo, Italy

AUSL Romagna - Ospedale Morgagni Pierantoni

Forlì, Italy

Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte

Lucca, Italy

AOU Pisana - Ospedale di Cisanello

Pisa, Italy

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NCT06388603


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