NCT03370874已完成3 期
Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年6月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportions of subjects who achieved complete wound closure
研究概览
简要总结
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
详细描述
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 75 years of age.
- •Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- •Foot ulcer size is between 1 cm2 and 15 cm2
- •Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
- •Free of necrotic debris at target ulcer
- •Around ulcer area blood circulation should be secured to meet one of below criteria;
- •Blood vessels around the ulcer detected by Doppler Test
- •0.7 < Ankle Brachial Index(ABI) < 1.3
- •Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
- •Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.
排除标准
- •Non-diabetic pathophysiologic ulcer.
- •The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- •Subjects requiring intravenous (IV) antibiotics to treat infection.
- •Current evidence of infection including pus drainage from the wound site.
- •Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
- •Subject's blood sugar is > 450 mg/dl at postprandial.
- •Subjects with severe renal failure that cannot be managed by renal dialysis.
- •Subjects with severe hepatic deficiencies.
- •Subject is Human Immunodeficiency Virus (HIV) positive.
- •Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- •Subject who is pregnant or breast-feeding.
- •Subjects who are unwilling to use an "effective" method of contraception during the study.
- •Subjects who have a clinically relevant history of alcohol or drugs abuse.
- •Subjects who are not able to understand the objective of this study or to comply with the study requirements.
- •Subjects who are considered to have a significant disease which can impact the study by investigator.
- •Subjects who are considered not suitable for the study by investigator.
- •Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
- •Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
- •Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
- •Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- •Subjects not comply with off-loading procedure
结局指标
主要结局
Proportions of subjects who achieved complete wound closure
时间窗: During 12 weeks
次要结局
- Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups(Follow up to 12 weeks)
- Change rates in wound size and depth compared to baseline between the two groups(During 12 weeks)
- Time taken to complete wound closure between the two groups(During 12 weeks)
- Proportions of subjects who achieved complete wound closure(Follow up to 12 weeks)
- Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations(Follow up to 12 weeks)
研究者
研究点 (1)
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