Using Bioactive Glass to Treat Diabetic Foot Osteomyelitis

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

This study is testing if adding a special type of glass to surgery can help diabetic patients with foot infections heal better and avoid complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: ASST Ovest Milanese (other)
• Locations: 7 sites (Monfalcone, Gorizia and 6 other locations)
• Trial ID: NCT06388603 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter randomized trial aimed at evaluating the effectiveness and safety of S53P4 bioactive glass in the surgical management of osteomyelitis in the forefoot of diabetic patients. Participants will be randomly assigned to two groups: one receiving standard surgical treatment with or without bone substitutes, and the other receiving debridement with the addition of bioactive glass. The study will monitor patient outcomes post-surgery, focusing on healing and infection control. The trial is conducted in specialized centers to ensure high-quality care and adherence to protocols.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type I or type II diabetes and a confirmed diagnosis of forefoot osteomyelitis that has not responded to antibiotic therapy.

Not a fit: Patients with metabolic decompensation or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve healing outcomes and reduce complications for patients with diabetic foot osteomyelitis.

How similar studies have performed: Previous studies have shown promise in using bioactive glass for bone healing, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Monfalcone, Gorizia and 6 other locations

• 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)

Study contacts

• Principal investigator: Dr. Roberto De Giglio, Med Doctor — ASST Ovest Milanese
• Study coordinator: Dr. Roberto De Giglio, Med Doctor

Conditions: Osteomyelitis - Foot, Diabetic Foot, Osteomyelitis, Forefoot