IRCT20240513061768N1已完成2 期
Comparison of the safety and efficacy of an alginate hydrogel dressing with placental-derived stem cells and an alginate hydrogel dressing with secretome in the treatment of diabetic foot ulcer resistant to standard treatment: a phase II clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Both male and female and over 18 years old
- •Ability to refer to course visits
- •Type 1 and 2 diabetes confirmed according to the guidelines of the American Diabetes Association
- •The presence of at least one or more diabetic foot ulcers with a size of less than 15 cm in their greatest diameter or a severity level of less than two according to the Texas classification
- •insulin or Drug therapy for control sugar
- •Having informed consent to participate in a clinical trial
排除标准
- •Any underlying disease that causes a change in the wound treatment process, such as cancer or immunodeficiency diseases
- •Renal Failure that requires dialysis
- •Degree of diabetic foot ulcer more than 2 based on Texas classification
- •Wound infection that indicates osteomyelitis based on clinical and laboratory evidence
- •Diagnosis of critical ischemia of the lower limbs that has been checked by Doppler ultrasound
- •Necrosis in distal wound
- •Pregnancy and breastfeeding
- •Mental and psychological problems that prevent the patient from making an independent decision to participate in the study
研究者
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