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New treatment option for Osteomyelitis - Foot
Official title RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)
ClinicalTrials.gov ID: NCT06388603
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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...
- 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...
You likely can't join 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...
- They should not have ESRD in dialysis.
See the full eligibility criteria
- 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...
- 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...
- Anatomical area: forefoot.
- 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 treatment studies within 45 days prior to the start of the present study.
- Predictable poor compliance or inability to communicate well with the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Monfalcone, Gorizia, Italy
- Abbiategrasso, Milano, Italy
- Abano Terme, Padova, Italy
- Arezzo, Italy
- Forlì, Italy
- Lucca, Italy
- Pisa, Italy
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monfalcone, Gorizia, Italy; Abbiategrasso, Milano, Italy; Abano Terme, Padova, Italy; Arezzo, Italy; Forlì, Italy; Lucca, Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.