Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds

Inclusion criteria

• Signed written informed consent obtained prior to the first study assessment;
• Male or female patients aged >= 20 and < 80 years;
• Diagnosed with diabetes mellitus (type 1 or type 2) with HbA1c < 12.0% detected during the screening period or within three months prior to randomization;
• Ankle-Brachial Index (ABI) of the target limb >= 0.8 measured during screening or within three months prior to randomization;
• The target ulcer must meet all of the following criteria: a. Wagner Ulcer Grading System grade 1 to 3; b. Located at or below the ankle; c. No infection or mild infection (as defined by IWGDF/IDSA criteria); d. Cross-sectional area after debridement between 1 and 25 cm²; e. Present for at least 4 weeks prior to randomization;
• For women of childbearing potential, negative pregnancy test and not currently breastfeeding at the screening visit;
• Willing and able to attend scheduled visits and comply with study procedures;

Exclusion criteria

• Presence of gangrene, suppuration, or sinus tract that cannot be removed by debridement;
• Diagnosis of acute Charcot neuroarthropathy based on clinical and/or radiographic examination;
• Undergone revascularization procedures aimed at increasing blood flow to the target limb within 4 weeks prior to randomization;
• Poor nutritional status, defined as albumin < 2.5 g/dL;
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal;
• Presence of acute biliary tract diseases such as acute cholecystitis or cholelithiasis;
• Serum creatinine > 2 times the upper limit of normal;
• Coagulation abnormalities, recent surgery, or severe trauma;
• Diagnosed with cerebral hemorrhage within 4 weeks prior to randomization;
• 10. Received immunosuppressants, chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to randomization;
• Use of any investigational drug or treatment within 4 weeks prior to randomization;
• Known allergy to curcumin or hydrogel;
• Pregnant or breastfeeding women;
• Psychiatric conditions (e.g., suicidal ideation), current or long-term alcohol or substance abuse, as determined by the patient's medical history, which in the investigator's opinion may compromise compliance;
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.