10 completed, 9 unknown, 6 terminated, 2 recruiting. 28 Phase 3, 10 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 28 | Completed 10, Unknown 9, Terminated 6, Recruiting 2, Active not recruiting 1 |
| Phase 2 | 10 | Unknown 7, Completed 2, Terminated 1 |
Follow Chronic Limb-Threatening Ischemia: new trials by email Literature Review of Chronic Limb-Threatening Ischemia trials Research Report on Chronic Limb-Threatening Ischemia
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 |
|---|---|---|---|---|---|---|
| Colchicine in Chronic Limb-Threatening Ischemia Colchicine 0.5 MG Oral Tablet Once Daily, Placebo - Chronic Limb-Threatening Ischemia | Phase 3 | Recruiting | Shin Kong Wu Ho-Su Memorial Hospital | 200 | 2026-06-02 | 2026-07-14 |
| Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee Temsirolimus, Saline placebo - Peripheral Artery Disease, Critical Limb Ischemia | Phase 3 | Recruiting | Mercator MedSystems, Inc. | 250 | 2025-07-30 | 2025-08-05 |
| Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients. Apixaban, ASA, Clopidogrel 75mg - Critical Limb Ischemia | Phase 3 | Unknown | Science Valley Research Institute | 200 | 2020-01-09 | 2021-04-20 |
| Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2) NL003, Normal Saline - Arterial Occlusive Disease, Ischemia | Phase 3 | Completed | Beijing Northland Biotech. Co., Ltd. | 242 | 2019-08-28 | 2024-09-20 |
| Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1) NL003, Normal Saline - Arterial Occlusive Disease, Ischemia | Phase 3 | Completed | Beijing Northland Biotech. Co., Ltd. | 302 | 2019-08-02 | 2024-09-19 |
| Trial to Assess Chelation Therapy in Critical Limb Ischemia Edetate Disodium, Placebo - Critical Limb Ischemia, Diabetes | Phase 3 | Active not recruiting | Mt. Sinai Medical Center, Miami | 50 | 2019-03-19 | 2026-07-01 |
| Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs Allogeneic Mesenchymal Stromal Cell, Placebo - Peripheral Arterial Disease, Cardiovascular Diseases | Phase 2 / Phase 3 | Unknown | Martin Teraa, MD, PhD | 60 | 2018-12-01 | 2018-05-03 |
| The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia Drug Eluting Stent - Below the Knee, Standard PTA Control Arm - Critical Limb Ischemia | Phase 3 | Completed | Boston Scientific Corporation | 201 | 2018-08-31 | 2024-07-01 |
| Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI) CardioCell, Placebos - Critical Limb Ischemia | Phase 2 / Phase 3 | Unknown | John Paul II Hospital, Krakow | 50 | 2018-04-19 | 2021-04-09 |
| 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 |
| An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Ranger SL DEB - Lower Limb Ischemia, Peripheral Vascular Diseases | Phase 2 / Phase 3 | Unknown | Assistance Publique - Hôpitaux de Paris | 30 | 2016-11-01 | 2018-05-18 |
| Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia HGF Plasmid (AMG0001), Matching Placebo - Critical Limb Ischemia | Phase 3 | Terminated | AnGes USA, Inc. | 46 | 2014-11-12 | 2019-08-13 |
| VADOplex Critical Limb Ischemia Study VADOplex system - Peripheral Artery Disease, Quality of Life | Phase 2 / Phase 3 | Unknown | Asklepios Kliniken Hamburg GmbH | 38 | 2013-10-01 | 2014-01-13 |
| Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells Peripheral blood mononuclear cell - Critical Limb Ischemia, Atherosclerosis | Phase 3 | Completed | Mahidol University | 8 | 2013-04-01 | 2018-08-17 |
| An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) Ixmyelocel-T, Placebo - Critical Limb Ischemia | Phase 3 | Completed | Vericel Corporation | 41 | 2012-02-01 | 2021-05-27 |
| Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries Self-expandable drug eluting stent - Peripheral Arterial Disease | Phase 2 / Phase 3 | Completed | Flanders Medical Research Program | 70 | 2012-01-01 | 2015-03-09 |
| Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia urokinase - Diabetic Foot, Critical Limb Ischemia | Phase 3 | Terminated | GWT-TUD GmbH | 34 | 2011-06-01 | 2014-04-07 |
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Peripheral Arterial Disease (10) · Peripheral Vascular Diseases (9) · Cardiovascular Diseases (3) · Diabetes Mellitus (3) · Arterial Occlusive Diseases (2) · Diabetes Mellitus, Type 1 (2) · Diabetes Mellitus, Type 2 (2) · Ischemia (2) · Ulcer (2) · Atherosclerosis (1) · Diabetic Foot (1) · Foot Ulcer (1) · Gangrene (1) · Intermittent Claudication (1)
Arteriosclerosis (28) · Chronic Disease (28) · Disease Attributes (28) · Pathologic Processes (28) · Pathological Conditions, Signs and Symptoms (28) · Atherosclerosis (27) · Vascular Diseases (27) · Arterial Occlusive Diseases (26) · Ischemia (26) · Cardiovascular Diseases (25) · Peripheral Vascular Diseases (19) · Peripheral Arterial Disease (18) · Endocrine System Diseases (4) · Glucose Metabolism Disorders (3) · Metabolic Diseases (3)
Injections (2) · Saline Solution (2) · treprostinil (2) · Aspirin (1) · Clopidogrel (1) · Colchicine (1) · Pentetic Acid (1) · Urokinase-Type Plasminogen Activator (1) · apixaban (1) · riferminogene pecaplasmide (1) · temsirolimus (1)
Beijing Northland Biotech. Co., Ltd. (2) · Ixaka Ltd (2) · United Therapeutics (2) · AnGes USA, Inc. (1) · Asklepios Kliniken Hamburg GmbH (1) · Assistance Publique - Hôpitaux de Paris (1) · Boston Scientific Corporation (1) · Cesca Therapeutics, Inc. (1) · Clinical Centre of Serbia (1) · Flanders Medical Research Program (1) · GWT-TUD GmbH (1) · Harvest Technologies (1) · John Paul II Hospital, Krakow (1) · Leiden University Medical Center (1) · Mahidol University (1)
United States (10) · Netherlands (6) · Germany (5) · Hungary (5) · Poland (5) · Belgium (4) · Czechia (4) · France (4) · Italy (3) · Spain (3) · United Kingdom (3) · Brazil (2) · Canada (2) · China (2) · Denmark (2)
Gilbert Wagener, MD (2) · Changwei Liu, MD (1) · Dalip Sethi, PhD (1) · Donna SH Lin, MD (1) · Enrico Maggi, professor (1) · Gert Jan de Borst, MD, PhD (1) · Gervasio Lamas, MD (1) · Hans Van Overhagen, MD PhD (1) · Hendrik van Overhagen, MD (1) · Holger Lawall, MD (1) · Jan HN Lindeman, MD, PhD (1) · Jihad Mustapha, MD (1) · Marc Bosiers, MD (1)
PMID 19700099, PMID 21621834, PMID 21696982, PMID 26861113, PMID 28351310, PMID 28411244, PMID 29242062, PMID 30004916, PMID 30686676, PMID 32730905, PMID 35802393, PMID 37844137, PMID 38294084
2014 (1)