Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Area of diabetic foot ulcers
研究概览
简要总结
The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome
详细描述
This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in calf of affected extrimity.
Study participants at the first study visit will complete study questionnaires, their foots will be assessed clinically for ulceration. After this initial assessment, the patients will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers due to diabetic foot syndrome.
At three month post-injection, the patient will complete study questionnaires, their foots will be assessed clinically for ulceration, and their foots will undergo non-invasive transcutaneous oximetry measurement. At six months post-injection, the patient will again complete study questionnaires, their foots will be assessed clinically for ulceration and will undergo non-invasive transcutaneous oximetry measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •obtained voluntary informed consent for participation in the clinical study
- •presence of diabetic foot syndrome
- •presence at least one active ulcer at baseline
排除标准
- •Any disease that can, in the opinion of the treating physician, affect the outcome of the study
- •Patients with addictive disorders or substance abuse
- •Pregnancy or nursing
- •All other exclusion criteria listed in the summary of product characteristics (SmPC)
研究组 & 干预措施
Neovasculgen
干预措施: Neovasculgen (Drug)
结局指标
主要结局
Area of diabetic foot ulcers
时间窗: 180 days
To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing
次要结局
- Transcutaneous oxygen pressure(180 days)