NCT00069446已完成1 期
An Exploratory, Double-Blind, Randomized, Placebo Controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Incidence of clinically significant hypotension.
研究概览
简要总结
This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Signed Informed Consent
- •18-80 years old
- •For females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (IUD); or contraceptive hormone implant or patch
- •Type 1 or 2 diabetes mellitus
- •Single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle
- •Chronic ulcer with a duration of ≥ 4 weeks but < 6 months
- •Ulcer area with sharp debridement of ≥ 1.0 cm^2 and ≤ 4.0 cm^2
- •Ankle-brachial index (ABI) of ≥ 0.6 and ≤ 1.2 on the study foot
- •Glycosylated hemoglobin A1c (HbA1c) of ≤ 12%
排除标准
- •History of neoplasia or current neoplasia (with the exception of non-melanoma skin cancer)
- •Proliferative diabetic retinopathy or wet age-related macular degeneration
- •Active ulcer infection or cellulitis of any ulcer
- •Ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult)
- •Connective tissue disease
- •Active osteomyelitis of the study foot
- •Subjects with ulcers related to an incompletely healed amputation wound
- •Subjects with Charcot or other deformity of the study foot involving the study ulcer
- •Immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy
- •Pregnancy or lactation
- •Multiple ulcers in the study foot
- •Renal failure (serum creatinine of >3.0 mg/dL)
- •Poor nutritional status (albumin of <3.0 g/dL)
- •Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate)
- •Known prior inability to complete required study visits during treatment period
- •Use of any other investigational drug or therapy on the study foot within the past month
- •Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months
结局指标
主要结局
Incidence of clinically significant hypotension.
次要结局
- Incidence of adverse events
- Percent reduction in total ulcer surface area.
- Development of anti telbermin antibodies
- Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL
研究者
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