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

Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Despite the availability of comprehensive multidisciplinary treatment approaches, the wound healing rate for DFU remains only approximately 50%. Therefore, the development of novel technologies for DFU wound management represents an urgent scientific priority. Our team has been dedicated to the DFU field for over 22 years and has established a well-maintained DFU follow-up cohort. In our preliminary work, we employed multi-omics approaches to analyze the microbial community structure and metabolite profiles of DFU wounds. Furthermore, we investigated the mechanisms of turmeric-derived nanoparticle in DFU wound infection and tissue repair based on the wound microenvironment. Building upon this foundation and utilizing a turmeric-derived hydrogel formulation, we plan to conduct a randomized, multi-center, parallel-controlled, prospective clinical study (N=112). This trial aims to evaluate the efficacy of turmeric-derived nanoparticle hydrogel as an adjunct to standard care in promoting target ulcer healing and reducing recurrent infections in patients with Wagner grade 1 to 3 DFU, with the goal of optimizing clinical practice in DFU wound management.

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.