Overview

The goal of this clinical trial is to learn if Curi01, a powder made of silica (silicon dioxide) particles, helps chronic, oozing diabetic foot ulcers heal when it is added to standard wound care. Curi01 is sprinkled directly onto the wound, where it soaks up wound fluid and forms a gel that is washed off at the next dressing change.

The main questions it aims to answer are:

Do more wounds heal completely within 12 weeks when Curi01 is added to standard wound care, compared with standard wound care alone? A wound counts as healed when it is fully closed and still closed 14 days later.

Is Curi01 safe and well tolerated?

Researchers will compare Curi01 plus standard wound care to standard wound care alone. Standard wound care includes removing dead tissue, cleaning the wound, non-medicated dressings and pressure relief for the foot if applicable.

Participants will:

Be adults with type 1 or type 2 diabetes who have an oozing foot ulcer (2 to 10 cm²) that has been present for at least 6 weeks and has not improved enough with standard wound care First receive standard wound care for 2 weeks to check whether the wound improves on its own Then be assigned by chance to one of the two groups; 2 out of 3 participants will receive Curi01 Visit the study site up to 18 times over about 14 weeks; in the Curi01 group, the powder is applied at each visit until the wound is dry Have their wound photographed and measured with a wound imaging app at each visit Answer questionnaires about their quality of life and how they feel their condition has changed Be asked about any side effects or health problems

About 280 participants will take part at around 20 study sites in Germany. Participants and doctors will know which treatment is being given.

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Granulating wounds in regeneration phase.
• 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).
• Wounds with sinuses and strong necrosis.
• 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.
• Previous treatment with a platelet derived growth factor (PDGF).
• Participation in another clinical trial within the last 4 weeks (i.e., 28 days) or previous participation in this clinical trial.
• 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%).
• Pregnant and/or breastfeeding women.
• Women of childbearing potential who do not use a highly effective method of contraception (i.e., Pearl Index ≤ 1).
• 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.
• Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the trial.