Clinical Trial Details
| Trial ID: | L6103 |
| Source ID: | NCT03174522 |
| Associated Drug: | Rex-001 |
| Title: | The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Peripheral Arterial Disease (PAD)|Diabetes Mellitus (DM)|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Cardiovascular Disease|Critical Limb Ischemia (CLI) |
| Interventions: | DRUG: REX-001|DRUG: Placebo |
| Outcome Measures: | Primary: Complete healing of all ischemic ulcers on the index leg., Change in Rutherford classification from CLI Category 5 to Category 4 or lower 12 months. after administration of REX-001 or placebo., The primary endpoint for this trial will be assessed at 12 months. | |
| Sponsor/Collaborators: | Sponsor: Ixaka Ltd | Collaborators: Andalusian Network for Design and Translation of Advanced Therapies |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 49 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-04-25 |
| Completion Date: | 2023-02-13 |
| Results First Posted: | |
| Last Update Posted: | 2023-03-16 |
| Locations: | Fakultní nemocnice Ostrava, Ostrava, Czechia|Pécsi Tudományegyetem, PTE-KK I. sz Belgyógyászati Klinika, Pécs, Hungary|Leids Universitair Medisch Centrum, Leiden, Netherlands|Maastricht Universitair Medisch Centrum, Maastricht, Netherlands|Hospital Garcia de Orta, EPE, Almada, Portugal|Centro Hospitalar Lisboa Norte, EPE, Lisboa, Portugal|Centro Hospitalar de São João, Porto, Portugal|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Universitario Puerta del Mar, Cadiz, Spain|First site: Hospital Universitario Reina Sofía, Córdoba, Spain|Hospital General Universitario Morales Meseguer, Murcia, Spain|Hospital Regional Universitario, Málaga, Spain|University Hospital of Wales, Cardiff, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT03174522 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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