EUCTR2016-003980-21-PT进行中（未招募）1 期
The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Ulcers in Subjects with Critical Limb Ischaemia Rutherford Category 5 and Diabetes Mellitus: a Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trial.
Rexgenero Limited0 个研究点目标入组 78 人开始时间: 2017年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Trial Population
- •Main inclusion Criteria
- •1. Aged = 18 to = 85 years.
- •2. Diagnosis of Type I or II DM, established more than one year ago.
- •3. Subjects with poor or no (surgical or endovascular) revascularization option classified as CLI Rutherford Category 5.
- •The blood circulation in these subjects must be compromised at screening, defined as:
- •Ankle systolic pressure < 70 mmHg, or
- •Toe systolic pressure < 50 mmHg, or
- •Transcutaneous oxygen pressure (tcpO2) < 30 mmHg (lying down).
- •Subjects with non-compressible vessels must qualify on toe pressure or tcpO2.
- •Poor or no revascularization option means that, in the opinion of the Investigator, revascularization using surgical or endovascular methods is not feasible due to unsuitable anatomy of existing vessels, existing comorbidity and/or previously failed surgical or endovascular revascularization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Main Exclusion Criteria
- •1. Advanced CLI defined as presence of major tissue loss (i.e, significant ulceration and/or gangrene) proximal to the metatarsal heads (CLI Rutherford Category 6). Significant ulceration/gangrene
- •means any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads.
- •2. CLI Rutherford Category 4.
- •3. Uncontrolled or untreated proliferative retinopathy.
- •4. Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening.
- •5. Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischaemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger's Disease), or systemic sclerosis (both limited and diffuse forms).
- •6. Clinical evidence of invasive infection on index leg defined as major tissue loss at the mid-foot or heel involving tendon and/or bone, and/or when according to the Investigator intravenous antibiotics are required to treat the infection.
- •7. At screening, the presence of only neuropathic ulcers on the index leg.
- •8. Amputation at or above the talus on the index leg.
- •9. Planned major amputation within the first month after randomization.
- •10. Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator.
研究者
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