Silica-Based Wound Treatment (Curi01) Plus Standard Care Versus Standard Care Alone for Chronic Diabetic Foot Wounds

Ki vehet részt

• Male, female or diverse patients aged ≥18 years at the time of signing the informed consent
• Willing and able to provide written informed consent
• Signed declaration of consent and signed data protection declaration after having been informed about the nature, relevance and the scope of the investigation and about the expected desired and undesired effects of the medical device
• Patients with stable diabetes mellitus type 1 or 2 (HbA1c level <12%) receiving antidiabetic treatment, if medically indicated. Historic values up to 6 months before Visit 1 may be used
• Chronic, exudating diabetic foot ulcer (DFU): Armstrong staging A or B, Wagner scale grades 1-2 and a wound surface between 2-10 cm². The foot is defined as the anatomical region distal to a line 3 cm proximal to the upper limit of the ankle joint; the target wound must be located within this region. "Chronic" is defined as present for at least 6 weeks prior to Screening Visit (Visit 1)
• Previous treatment of DFU with standard of care (SoC) for at least 2 weeks before Baseline Visit (Visit 2), without relevant improvement (i.e., <30% wound area reduction between Screening Visit (Visit 1) and Baseline Visit (Visit 2))
• Patients without wound infection or with mild wound infection ("mild" is defined as no antibiotic therapy is needed for the treatment of the infected wound). In the case of wound infection, antibiotic treatment must be stopped at least 48 hours prior to Visit 1
• No amputation history driven by a diabetic cause in the target wound limb within the 12 months prior to Screening Visit (Visit 1)
• Outpatients in an ambulatory setting
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of Screening Visit (Visit 1) are acceptable (may also be the status after revascularization):; Ankle-Brachial-Index (ABI) between 0.6 and 1.4; Toe-Brachial-Index (TBI) ≥ 0.7; Pulse Volume Recording (PVR): biphasic; Imaging procedure that rules out critical ischemia (duplex sonography, computed tomography or magnetic resonance angiography)

Ki nem vehet részt

• Wounds with a necrotic eschar (dry or wet) which cannot be debrided without surgery (i.e., without surgical debridement which would require an operating room and anesthesia)
• Autolytic debridement as pre-treatment within one month prior to enrollment
• Immunosuppressed patients (uncontrolled immunological disease, active systemic infection, and/or receiving immunosuppressive therapy). Corticosteroids with a daily dose of ≤ 5 mg prednisone (or equivalent) are acceptable
• Participation in another clinical trial within the last 4 weeks (i.e., 28 days) or previous participation in this clinical trial
• Patients with silica hypersensitivity or allergy
• Any other condition/treatment that the investigator considers may compromise the patients' safety and/or the integrity of the data
• Previous treatment with a platelet derived growth factor (PDGF)
• Active cancer disease, osteomyelitis, known coagulation disorders (i.e., clinically relevant primary procoagulant coagulation disorders that require specific treatment, e.g., thrombophilia; secondary prophylactic anticoagulation is not excluded), known severe renal complications (dialysis, glomerular filtration rate [GFR] below 30 mL/min), symptomatic congestive heart failure (ejection fraction <30%)
• Granulating wounds in regeneration phase
• Wounds with sinuses and strong necrosis
• Pregnant and/or breastfeeding women
• Women of childbearing potential who do not use a highly effective method of contraception (i.e., Pearl Index ≤ 1)
• Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the trial