NCT00915486已完成2 期
A Randomized, Multi-center, Controlled, Parallel Group, Dose Finding Study of the Efficacy and Safety of Topically Applied I-020201 as an Adjunct to Good Standard-of-care Versus Good Standard-of-care Alone in Patients With Chronic Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 68
- 主要终点
- Percentage reduction in ulcer surface area
研究概览
简要总结
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. The large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female, aged ≥ 18 years
- •given written informed consent
- •female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
- •Type 1 or Type 2 Diabetes mellitus with HbA1c =< 12%
- •with only one diabetic foot ulcer on the foot to be treated on or below the ankle
排除标准
- •pregnant or breast-feeding
- •known or suspected allergies to any of the components of the I-020201
- •uncontrolled anemia (Hb < 9 g/dL in females and < 10 g/dL in males)
- •hypoalbuminemia (albumin < 3 g/dL)
- •overtly infected target ulcer (as judged by investigator)
- •highly exuding wounds (wounds that require a daily dressing change)
- •osteomyelitis
- •systemic infections
- •acute Charcot foot and severe chronic Charcot deformity
- •ABPI < 0.7 or ankle systolic pressure < 70 mm Hg
- •one of the following findings (only 1 out of 3 tests is required):
- •on Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries a monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or
- •a toe: brachial index < 0.7, or
- •transcutaneous oxygen pressure (TcpO2) < 40 mm Hg
- •suspicion, presence or history of systemic or local cancer or tumor of any kind
结局指标
主要结局
Percentage reduction in ulcer surface area
时间窗: 4 weeks after treatment start
次要结局
- Incidence of complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards)(Within the whole study period (28 weeks after treatment start))
- Time to complete wound closure (full re-epithelialization with confirmation 4 weeks afterwards).(At any time during the study)
- Incidence of treatment failure defined as <30% decrease in ulcer size(After 8 weeks of treatment)
- Incidence of patients with ulcer recurrence(Up to 16 and 28 weeks after treatment start)
- Incidence of treatment-related adverse events (systemic and at the target ulcer) and all AEs/SAEs(During the whole study period)
- Changes in systemic PDGF-AB and antibody levels against TG-PDGF.AB and aprotinin(At 1, 4, 12, 16 and 20 weeks after treatment start)
- Changes in vital signs, body weight, physical examination and laboratory parameters(Throughout the study and 28 weeks after treatment start)
研究者
研究点 (68)
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