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

ASST Ovest Milanese

Status: Enrolling

Conditions: Osteomyelitis - Foot

Treatments: Other: Standard of Care; Device: Bioactive Glass

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06388603

DFORCT012023

Details and patient eligibility

About

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.

Full description

Patient with a diagnosis of ostemileytis localised in the forefoot will be 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.

In any case a primary intent closure is pursued, both in Group A and B, a vacuum percutaneous drainage would be placed before closing the wound and removed in 2nd post-operative day, if necessary, by the surgeon.

Systemic antibiotic therapy will be started immediately on empirical basis, as per normal practice.

After the removal of drainage, or after the first post-operative control in 2nd post-operative day, as done routinely at study sites, patients will be evaluated biweekly either if they are still admitted or if they were dismissed and will be followed up by investigators blinded toward the groups.

At each visit local conditions and eventual dressing changes will be recorded, alongside with any possible complication, like non-healing, re-infection, and any systemic and local adverse event.

Patients will be followed every second week up to 3 months or until complete healing and then at six months and 12 months from surgical interventions. At six-month and 12 -month follow-up, rate of healing and recurrences will be checked; x-rays will be performed at pre-operation visit, immediate post and at 12 months Follow Up visit. Histopathological samples collected as per normal practice during the surgery will be analyzed with standard protocol in local laboratories. Healing will be defined as complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits. For the sake of calculating healing time, healing will be attributed to the first visit. At each visits a local and systemic evaluation of the wound will be done as per normal practice. A photo of the wound will be taken at visits: Pre-operative , Immediate post-op, 6 weeks post-op, 6 months and 12 months after the surgical procedure. Laboratory exams will be performed as per hospital standard of care. At pre-operative and 6 months and 12 months visits patients compile Quality of Life and Foot Function Index Questionnaires.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Standard of Care - Osteomyelitis treatment

Active Comparator group

Description:

Subjects randomized in this group will be treated according to standard of care for the surgical managment of Osteomyelitis in the forefoot in patient suffering from diabetic foot syndrome. All standard of care approaches will be allowed (e.g use of bone sobsitutes, cements, cements loaded with antibiotics etc) with the only exception of Bioactive Glasses.

Treatment:

Other: Standard of Care

Bioactive Glass

Experimental group

Description:

Subjects randomized in this group will be treated using the S53P4 Bioactive Glass of Bonalive Biomaterials Ltd; in the form of: * Bonalive Granules 2.5 CC (0.5-0.8 MM) * Bonalive Putty 2.5 CC (SIRINGA 0.5-0.8 MM) The quantity that will be implanted will vary according to the bone cavity of each patient.

Treatment:

Device: Bioactive Glass