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

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

December 30, 2026

Conditions
Osteomyelitis - Foot
Interventions
DEVICE

Bioactive 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.

OTHER

Standard 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.

Trial Locations (7)

5612

NOT_YET_RECRUITING

AOU Pisana - Ospedale di Cisanello, Pisa

20081

RECRUITING

ASST Ovest Milanese - Ospedale di Abbiategrasso, Abbiategrasso

34074

NOT_YET_RECRUITING

ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone, Monfalcone

35031

NOT_YET_RECRUITING

Casa di Cura Abano Terme - POLICLINICO ABANO TERME, Abano Terme

47121

NOT_YET_RECRUITING

AUSL Romagna - Ospedale Morgagni Pierantoni, Forlì

52100

NOT_YET_RECRUITING

USL Sud Est Toscana - Ospedale San Donato, Arezzo

55100

NOT_YET_RECRUITING

Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte, Lucca

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hippocrates Research

OTHER

collaborator

Bonalive Biomaterials Ltd

INDUSTRY

lead

ASST Ovest Milanese

OTHER

NCT06388603 - RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT) | Biotech Hunter | Biotech Hunter