NCT03754465已完成2 期
A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年1月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 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 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
详细描述
- Active Group: ALLO-ASC-SHEET
- Control Group: Hydrogel SHEET (vehicle control)
- Study Type: Interventional
- Study Design: Randomized, Comparator-controlled, Double-blind, 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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 80 years of age.
- •Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- •Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm
- •Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
- •Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
- •Ulcer area blood circulation meets one of the following criteria
- •A. Blood vessels around the ulcer detected by Doppler Test
- •B. range of Ankle Brachial Index(ABI) was > 0.7 to < 1.3
- •C. Transcutaneous oxygen pressure, (TcPO2) > 30 mmHg.
- •Is able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Ulcer is of non-diabetic pathophysiology.
- •The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
- •Is Human Immunodeficiency Virus (HIV) positive?
- •Have severe hepatic deficiencies.
- •Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
- •Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- •Require intravenous (IV) antibiotics to treat the target wound infection.
- •Have severe renal failure including subject on renal dialysis.
- •Pregnant or breast-feeding.
- •Is unwilling to use an "effective" method of contraception during the study.
- •Have evidence of current infection including pus drainage from the wound site.
- •Have a clinically relevant history of alcohol or drugs abuse.
- •Have postprandial blood sugar > 350 mg/dl.
- •Is not able to understand the objective of this study or to comply with the study requirements.
- •Is considered by the investigator to have a significant disease which might have impacted the study.
- •Is considered not suitable for the study by investigator.
- •Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
- •Is currently or were enrolled in another clinical study within 60 days of screening.
- •Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
- •Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- •Cannot maintain off-loading process
- •Panel reactive antibody (PRA) levels ≥ 20%
研究组 & 干预措施
ALLO-ASC-DFU
Experimental
Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
干预措施: ALLO-ASC-DFU (Biological)
Hydrogel SHEET(Vehicle control)
Placebo Comparator
Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
干预措施: Hydrogel SHEET(Vehicle control) (Procedure)
结局指标
主要结局
Proportions of subjects who achieved complete wound closure
时间窗: During 12 weeks
Proportions of subjects who achieved complete wound closure
次要结局
- Time to initial complete wound closure between the two groups(During 12 weeks)
- Durability of complete wound closure(Follow up to 24 weeks from the initial complete wound closure.)
- Changes in wound size compared to baseline between the two groups(During 12 weeks)
- Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups(During 12 weeks(at every visit during treatment period))
研究者
研究点 (1)
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