EUCTR2016-003980-21-HU
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 - Salamander
Rexgenero Limited0 个研究点目标入组 78 人2017年3月20日
适应症Critical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1 Level: LLT Classification code 10077142 Term: Limb ischemia System Organ Class: 100000004866MedDRA version: 21.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Critical Limb Ischemia in patients with Diabetes Mellitus
- 发起方
- Rexgenero Limited
- 入组人数
- 78
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
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).
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 ischemia or an immunological or inflammatory or non\-atheroscalerotic 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.
结局指标
主要结局
未指定
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