NL-OMON55357已完成3 期
The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects with Chronic Limb Threatening Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial - REX-001-005 Rutherford Category 5
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged >= 18 to <= 85 years.
- •2. Diagnosis of Type I or II DM, established more than one year ago.
- •3. Glycosylated hemoglobin (HbA1c) < 9%.
- •4. Subjects with poor or no (surgical or endovascular) revascularization option
- •classified as CLTI Rutherford Category 5.
- •The blood circulation in these patients must be compromised at screening, can
- •be defined as:
- •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 measurements must be performed and only one may be used
- •to meet this criteria
排除标准
- •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 ischemia 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
- •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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