7 completed, 3 terminated, 2 active not recruiting, 2 recruiting. 6 Not applicable, 4 Phase 1, 4 Phase 2, 4 Phase 3.
Follow Critical Limb Ischemia (CLI): new trials by email Literature Review of Critical Limb Ischemia (CLI) trials Research Report on Critical Limb Ischemia (CLI)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry intensive toe pressure evaluation, data collection - Critical Limb Ischemia (CLI) | Not applicable | Not yet recruiting | University Hospital, Bordeaux | 200 | 2025-07-07 | 2025-06-10 |
| Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L) NL003, Placebo - Peripheral Arterial Disease(PAD), Arterial Occlusive Disease | Enrolling by invitation | Beijing Northland Biotech. Co., Ltd. | 542 | 2025-06-30 | 2025-07-11 | |
| Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery Implantation of RFS - Critical Limb Ischemia (CLI) | Not applicable | Recruiting | Stentit | 10 | 2025-06-03 | 2025-07-09 |
| Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions Peripheral Arterial Disease, Critical Limb Ischemia (CLI) | Recruiting | Dr. Konstantinos Katsanos | 100 | 2024-09-01 | 2025-07-04 | |
| Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI Popliteal sciatic nerve block - Critical Limb Ischemia (CLI), Popliteal Nerve Block | Completed | Minia University Hospital | 70 | 2024-03-20 | 2025-04-06 | |
| LIFE-BTK PK Sub-study Esprit BTK Device - Critical Limb Ischemia (CLI) | Not applicable | Active not recruiting | Abbott Medical Devices | 9 | 2022-02-10 | 2026-01-26 |
| IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device - Critical Limb Ischemia (CLI) | Not applicable | Unknown | Biotyx Medical (Shenzhen) Co., Ltd. | 120 | 2021-12-09 | 2022-03-17 |
| DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease POBA, Scoring Balloon - Femoropopliteal Disease, Drug Coated Balloon | Not applicable | Completed | Marc Sirvent | 83 | 2020-09-25 | 2025-08-29 |
| LIFE-BTK Randomized Controlled Trial Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device - Critical Limb Ischemia (CLI) | Not applicable | Active not recruiting | Abbott Medical Devices | 261 | 2020-08-18 | 2025-12-30 |
| Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization PLX-PAD, Placebo - Critical Limb Ischemia (CLI) | Phase 3 | Completed | Pluristem Ltd. | 213 | 2017-05-22 | 2024-08-30 |
| The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM REX-001, Placebo - Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM) | Phase 3 | Terminated | Ixaka Ltd | 49 | 2017-04-25 | 2023-03-16 |
| The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM REX-001, Placebo - Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM) | Phase 3 | Terminated | Ixaka Ltd | 3 | 2017-04-05 | 2021-05-07 |
| Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System Autologous Bone Marrow Concentrate (aBMC), Placebo Control (diluted autologous peripheral blood) - Critical Limb Ischemia (CLI) | Phase 3 | Unknown | Cesca Therapeutics, Inc. | 224 | 2017-01-01 | 2016-07-28 |
| Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin Stem cell infusion - Critical Limb Ischemia (CLI) | Phase 1 / Phase 2 | Terminated | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | 20 | 2011-09-01 | 2018-12-19 |
| Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI) Magellan® - Critical Limb Ischemia (CLI), Peripheral Vascular Disease (PVD) | Phase 1 | Completed | Arteriocyte, Inc. | 18 | 2011-04-01 | 2017-01-24 |
| Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI). Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells - Critical Limb Ischemia (CLI) | Phase 2 | Completed | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | 38 | 2011-01-01 | 2016-03-16 |
| Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients Autologous adipose derived mesenchymal stem cells - Critical Limb Ischemia (CLI), Diabetes | Phase 1 / Phase 2 | Completed | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | 33 | 2010-12-01 | 2015-08-05 |
| Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization Intraarterial infusion of autologous bone marrow cells - Critical Limb Ischemia (CLI), Diabetic Foot | Phase 1 / Phase 2 | Completed | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | 60 | 2009-07-01 | 2016-03-16 |
| Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI) PLX-PAD - Critical Limb Ischemia (CLI) | Available | WideTrial, Inc. | 2019-01-08 | |||
| Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization PLX-PAD - Critical Limb Ischemia (CLI) | No longer available | Pluristem Ltd. | 2024-09-19 |
Chronic Limb-Threatening Ischemia (20) · Peripheral Arterial Disease (5) · Diabetes Mellitus (3) · Cardiovascular Diseases (2) · Diabetes Mellitus, Type 1 (2) · Diabetes Mellitus, Type 2 (2) · Diabetic Foot (2) · Arterial Occlusive Diseases (1) · Arteriosclerosis Obliterans (1) · Peripheral Vascular Diseases (1) · Thromboangiitis Obliterans (1)
Arteriosclerosis (20) · Atherosclerosis (20) · Chronic Disease (20) · Disease Attributes (20) · Ischemia (20) · Pathologic Processes (20) · Pathological Conditions, Signs and Symptoms (20) · Vascular Diseases (20) · Arterial Occlusive Diseases (19) · Peripheral Vascular Diseases (19) · Cardiovascular Diseases (18) · Peripheral Arterial Disease (15) · Endocrine System Diseases (5) · Glucose Metabolism Disorders (3) · Metabolic Diseases (3)
Angioplasty (2) · Control Groups (1) · Data Collection (1)
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud (4) · Abbott Medical Devices (2) · Ixaka Ltd (2) · Pluristem Ltd. (2) · Arteriocyte, Inc. (1) · Beijing Northland Biotech. Co., Ltd. (1) · Biotyx Medical (Shenzhen) Co., Ltd. (1) · Cesca Therapeutics, Inc. (1) · Dr. Konstantinos Katsanos (1) · Marc Sirvent (1) · Minia University Hospital (1) · Stentit (1) · University Hospital, Bordeaux (1) · WideTrial, Inc. (1)
Spain (7) · United States (5) · Czechia (3) · Hungary (3) · Australia (2) · China (2) · Germany (2) · Poland (2) · Portugal (2) · Taiwan (2) · United Kingdom (2) · Austria (1) · Bulgaria (1) · Egypt (1) · France (1)
Antonio Chacon, MD, PhD (2) · Diego Martinez, MD, PhD (2) · Gilbert Wagener, MD (2) · Inmaculada Herrera, MD, PhD (2) · Amr Nady Abd Elrazik, assistant professor (1) · Andres Garcia, MD, PhD (1) · Antonio De la Cuesta, MD (1) · Bernat Soria (1) · Brian DeRubertis, MD, FACS (1) · Dalip Sethi, PhD (1) · Fernando Calleja, MD, PhD (1) · Francisco Tadeo Gomez, MD, PhD (1) · Jose P Linares, MD, PhD (1) · Jose Patricio Linares, MD, PhD (1)
PMID 30686676, PMID 37888915, PMID 38294084, PMID 40927852, PMID 42126372, PMID 42242352
2008 (1), 2009 (1)