Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 主要终点
- target ulcer healing rate
研究概览
简要总结
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 and a comprehensive biospecimen repository. 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 aerogel (TAG) in DFU wound infection and tissue repair based on the wound microenvironment. These findings were published in Advanced Science in 2024.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=54). This trial aims to evaluate the efficacy of TAG 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
declarant
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
TAG group
TAG adjunctive treatment group
干预措施: TAG adjunctive treatment group (Drug)
Placebo control group
Hydrogel adjunctive treatment group
干预措施: Hydrogel adjunctive treatment group (Drug)
结局指标
主要结局
target ulcer healing rate
时间窗: 12weeks
Ulcer area was measured and recorded using digital photography and ImageJ software.
次要结局
未报告次要终点