EUCTR2016-003980-21-LT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 Chronical Limb Threatening Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial - Salamander
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •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 CLTI Rutherford
- •Category 5. The blood circulation in these subjects must be compromised at screening and can be defined
- •Ankle systolic pressure < 70 mmHg, or
- •Toe systolic pressure < 50 mmHg, or
- •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.
- •IMPORTANT: All three pressures measurements must be performed and only one may be used to meet
- •this criteria
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Main Exclusion Criteria
- •1. Advanced CLTI defined as presence of major tissue loss (i.e, significant ulceration and/or gangrene)
- •proximal to the metatarsal heads (CLTI 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. CLTI 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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