NCT04569409已完成3 期
Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-controlled, Double-blind, Parallel-group, Multi-center Study
Anterogen Co., Ltd.5 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2020年7月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 5
- 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 Wagner grade 2 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
- 19 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 19 and 75 years of age.
- •Subject is diagnosed with Type I or Type II diabetics.
- •Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
- •Ulcer located in the foot and ulcer size is between 1.5~15 cm
- •Ulcer graded 2 by Wagner grade.
- •Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
- •Ulcer is free of necrotic debris.
- •Ulcer area blood circulation meets one of the following criteria;
- •Blood vessels around the ulcer detected by Doppler Test
- •Range of Ankle Brachial Index (ABI) is > 0.7 to < 1.3
- •Transcutaneous Oxygen Pressure (TcPO2) > 30mmHg or Toe Blood Pressure (TBP) > 40mmHg.
- •Skin Perfusion Pressure (SPP) > 30mmHg
- •Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.
排除标准
- •Ulcer is of non-diabetic pathophysiology.
- •There is gangrene in any part of the target foot ulcer.
- •The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
- •Other wounds within 2cm of the target foot ulcer.
- •The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
- •Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
- •Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
- •Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer.
- •An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
- •Have a glycated hemoglobin A1c (HbA1c) level of > 14%
- •Have random blood sugar > 450mg/dL
- •Have severe renal failure with creatinine > 3.0mg/dL.
- •Have severe hepatic deficiencies
- •Total bilirubin ≥ 1.5×upper normal limit(UNL)
- •AST, ALT ≥ 2.0×UNL
- •Serum albumin < 2.0mg/dL
- •Is Human Immunodeficiency Virus (HIV) positive
- •Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
- •Pregnant or breast-feeding.
- •Is unwilling to use an acceptable method of birth control during the whole study.
- •Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
- •Is not able to understand the objective of the study or to comply with the study requirements
- •Is considered by the Investigator to have a significant disease which might impact the study
- •Is considered not suitable for the study by Investigator
- •Have a history of malignancy within the last 5 years (except carcinoma 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, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
- •Cannot maintain off-loading process and device.
研究组 & 干预措施
ALLO-ASC-DFU
Experimental
Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
干预措施: ALLO-ASC-DFU (Biological)
Vehicle sheet
Placebo Comparator
Hydrogel sheet without allogenic mesenchymal stem cell
干预措施: Vehicle Sheet (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
- Time taken to complete wound closure(During 12 weeks)
- Proportions of subjects who achieved complete wound closure at every visit(During 12 weeks)
- Change rates in wound size and depth compared to baseline groups(During 12 weeks)
研究者
研究点 (5)
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