EUCTR2016-000240-34-AT
Active, not recruiting
Phase 1
The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischaemic Rest Pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial
Rexgenero Limited0 sites60 target enrollmentMay 25, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Rexgenero Limited
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 4\.
- •The blood circulation in these subjects must be compromised at screening, defined as:
- •Ankle systolic pressure \< 50 mm Hg, or
- •Toe systolic pressure \< 30 mm Hg, or
- •Transcutaneous oxygen pressure (tcpO2\) \< 30 mm Hg, and
- •Flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR)
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 5\.
- •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.
Outcomes
Primary Outcomes
Not specified
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