NCT00387101终止3 期
Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- ApoPharma
- 入组人数
- 288
- 试验地点
- 24
- 主要终点
- To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
详细描述
The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signed a written informed consent prior to the first study intervention
- •Is at least 18 and <85 years of age
- •Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
- •Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
- •Has a maximum fasting blood glucose level of 13.8 mmol/L
- •An ankle-brachial systolic pressure index between 0.7 and 1.3
- •If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
- •Able and willing to attend the scheduled visits and comply with study procedures.
排除标准
- •Known or suspected disease of the immune system
- •Active or untreated malignancy or active, uncontrolled connective tissue disease
- •Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
- •Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
- •Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
- •Active febrile illness
- •AST, ALT, ALP >3x the normal upper limit
- •Serum Creatinine >2x the normal upper limit
- •Osteomyelitis
- •Active Charcot
- •Use of any topical treatments other than SOC (standard of care)at the time of enrollment
- •Enrollment in any investigational clinical trial within 30 days of the screening visit
- •Known or suspected hypersensitivity to any study product components
- •Recent or current history of alcohol or drug abuse
- •Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
- •All site personnel directly affiliated with this study and their immediate families
结局指标
主要结局
To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone.
次要结局
未报告次要终点
研究者
研究点 (24)
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