Actively Recruiting
RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)
Led by ASST Ovest Milanese · Updated on 2024-04-29
140
Participants Needed
7
Research Sites
144 weeks
Total Duration
On this page
Sponsors
A
ASST Ovest Milanese
Lead Sponsor
H
Hippocrates Research
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Male or female patients aged 18 years or older.
- Type 1 diabetes for at least 5 years or type 2 diabetes.
- Diagnosis of osteomyelitis in the forefoot confirmed by imaging and culture, unresponsive to 2 to 6 weeks of antibiotic therapy and/or associated with soft tissue infection, abscess, phlegmon, or necrosis requiring surgical debridement.
- Palpable pulses on tibial posterior or dorsalis pedis artery at the ankle in the affected limb, and/or ankle-brachial pressure index between 0.7 and 1.2, and/or transcutaneous oxygen pressure at dorsum of the foot ≥36 mmHg.
- Ability and willingness to comply with study procedures and offloading prescriptions and to attend scheduled visits.
- Osteomyelitis localized to the forefoot.
You will not qualify if you...
- Metabolic decompensation with HbA1c >109 mmol/mol (>12%).
- Major amputation on the opposite limb.
- Acute or chronic Charcot's foot in the affected foot.
- Surgical or endovascular revascularization of the affected foot within 1 month before enrollment.
- Use of corticosteroids, bisphosphonates, immunosuppressants, or other drugs interfering with bone metabolism or tissue repair.
- End-stage renal disease on dialysis.
- Bedridden or unable to walk.
- Life expectancy less than 1 year.
- Unable to undergo surgery under loco-regional anesthesia.
- Severe diseases interfering with expected disease course or therapy.
- Hypersensitivity or anaphylactic reactions to any product ingredient.
- Participation in another interventional study within 45 days prior to this study.
- Poor compliance or inability to communicate effectively with investigators.
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Trial Site Locations
Total: 7 locations
1
ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone
Monfalcone, Gorizia, Italy, 34074
Not Yet Recruiting
2
ASST Ovest Milanese - Ospedale di Abbiategrasso
Abbiategrasso, Milano, Italy, 20081
Actively Recruiting
3
Casa di Cura Abano Terme - POLICLINICO ABANO TERME
Abano Terme, Padova, Italy, 35031
Not Yet Recruiting
4
USL Sud Est Toscana - Ospedale San Donato
Arezzo, Italy, 52100
Not Yet Recruiting
5
AUSL Romagna - Ospedale Morgagni Pierantoni
Forlì, Italy, 47121
Not Yet Recruiting
6
Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte
Lucca, Italy, 55100
Not Yet Recruiting
7
AOU Pisana - Ospedale di Cisanello
Pisa, Italy, 5612
Not Yet Recruiting
Research Team
D
Dr. Roberto De Giglio, Med Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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