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

Recruiting now · Not applicable

Conditions studied: Osteomyelitis - Foot

In brief

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.

Key facts

Study ID

NCT06388603

Run by

ASST Ovest Milanese

People needed

140

Starts

2024-03-21

Expected to finish

2026-12-30

Last updated by the study team

2024-04-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained.
• Male or female patients >= of 18 years old.
• They should have type I since at least 5 years or type II DM
• 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.
• 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.
• 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.
• Anatomical area: forefoot.

You may not qualify if…

• They should not have metabolic decompensation as witnessed by HbA1c >109 mmol/mol (> 12%).
• They should not have major amputation on the contra-lateral limb.
• They should not have acute or chronic Charcot's foot in the affected foot.
• They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment.
• 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.
• They should not have ESRD in dialysis.
• They should not be bedridden or not ambulating.
• They should not have a life expectancy shorter than one year.
• They should not be too ill to sustain a surgical procedure under loco-regional anesthesia.
• They should not have severe disease which might interfere with the expected course of the disease and therapy.
• Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions.
• Participation in another interventional studies within 45 days prior to the start of the present study.
• Predictable poor compliance or inability to communicate well with the investigator.

Where it is running

• ASST Ovest Milanese - Ospedale di Abbiategrasso — Abbiategrasso, Milano, Italy (enrolling)
• Casa di Cura Abano Terme - POLICLINICO ABANO TERME — Abano Terme, Padova, Italy
• ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone — Monfalcone, Gorizia, 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
• USL Sud Est Toscana - Ospedale San Donato — Arezzo, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.