RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)
ConditionOsteomyelitis - Foot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorASST Ovest Milanese
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bioactive Glass
DeviceBonalive 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.
Standard of Care
Other interventionThe 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard of Care - Osteomyelitis treatmentActive comparator 1 intervention
Group B: Bioactive GlassExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
healing rate
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.
Time frame
6-monthSecondary outcomes
1
Duration of antibiotic therapy
systemic antibiotic therapy will be prescribed after intervention and its duration can vary according to infection state.
Time frame
through study completion, an average of 1 year2
Rate of recurrences
After intervention bone infections proper of osteomyelitis can recur
Time frame
6-months and 12-month3
Number of re-interventions because of the same lesion
If an infection recur might be necessery to procede with a re-intervention.
Time frame
through study completion, an average of 1 year4
Timing of re-interventions because of the same lesion
If an infection recur might be necessery to procede with a re-intervention.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
ASST Ovest Milanese
Lead sponsor
Hippocrates Research
Collaborator
Bonalive Biomaterials Ltd
Collaborator
Source ClinicalTrials.gov