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

Inclusion Criteria: 1. Written informed consent obtained. 2. Male or female patients \>= of 18 years old. 3. They should have type I since at least 5 years or type II DM 4. They should have a diagnosis - confirmed by imaging and culture - of OM localized in the forefoot not responding for at least 2 up to 6 weeks to systemic antibiotic therapy and/or associated with soft tissue infection, abscess, phlegmon, necrosis, and for which a surgical debridement is indicated. 5. They should have palpable pulses on TP or DP at the ankle in the affected limb, and/or ABPI \>0.7 and \<1.2 and /or TcPO2 at dorsum of the foot ≥36 mmHg. 6. They should be able to accomplish with the procedures and prescriptions indicated by the Study protocol, particularly with the offloading prescription, as well as they should be willing and able to attend and respect the program of control visits and medications. 7. Anatomical area: forefoot. Exclusion Criteria: 1. They should not have metabolic decompensation as witnessed by HbA1c \>109 mmol/mol (\> 12%). 2. They should not have major amputation on the contra-lateral limb. 3. They should not have acute or chronic Charcot's foot in the affected foot. 4. They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment. 5. They should not be taking corticosteroids, bisphosphonates, immunosuppressants, and more in general any drug which might interfere with bone metabolism or tissue repair, in thejudgment of investigators. 6. They should not have ESRD in dialysis. 7. They should not be bedridden or not ambulating. 8. They should not have a life expectancy shorter than one year. 9. They should not be too ill to sustain a surgical procedure under loco-regional anesthesia. 10. They should not have severe disease which might interfere with the expected course of the disease and therapy. 11. Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions. 12. Participation in another interventional studies within 45 days prior to the start of the present study. 13. Predictable poor compliance or inability to communicate well with the investigator.