EUCTR2016-003980-21-PT
Active, not recruiting
Phase 1
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 sites78 target enrollmentStarted: June 7, 2017Last updated:
ConditionsCritical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866MedDRA version: 24.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Rexgenero Limited
- Enrollment
- 78
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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.
Investigators
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