Clinical trials: Critical Ischemia Limb
Critical Limb Ischemia
Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery.
- Trial name
- EXERCISE (NCT04043078)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Peripheral Artery Disease, Peripheral Vascular Disease
The VaSecure BTK Study
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease
- Trial name
- NCT03638115
- Testing
- VaSecure™
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 46 people
- Sponsor
- Vascuros Medical Pte Ltd
Critical Limb Ischemia
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.
- Trial name
- NCT02941419
- Testing
- Platelet lysate
- Volunteers
- 10 people
- Sponsor
- University of Jordan
Chronic Limb-Threatening Ischemia
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Trial name
- ELITE-BTK (NCT06071429)
- Testing
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- R3 Vascular Inc.
Diabetes, Critical Limb Ischemia
Feasibility of Peripheral Angioplasty in Type D TASCII Lesions
This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria.
- Trial name
- NCT01297387
- Testing
- PTA BPG procedure,
- Where
- Italy
- Volunteers
- 344 people
- Sponsor
- IRCCS Multimedica
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03111238
- Testing
- REX-001
- Where
- 15 sites in Czechia, Germany and 4 more
- Volunteers
- 3 people
- Sponsor
- Ixaka Ltd
Critical Limb Ischemia
Autologous Endothelial Progenitor Cells (EPCs) From Peripheral Blood in the Treatment of Critical Limb Ischemia
Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.
- Trial name
- NCT01595776
- Testing
- Endothelial progenitor cells intramuscular implant
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Peripheral Arterial Disease, Critical Limb Ischaemia
Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
- Trial name
- NCT02634138
- Testing
- Revitive IX
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Imperial College London
Critical Limb Ischemia, Diabetic Foot
Autologous Peripheral Blood Mononuclear Cells in Diabetic Foot Patients With No-option Critical Limb Ischemia
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
- Trial name
- NCT04255004
- Testing
- Pall Celeris System, point of care device for human cell therapy
- Volunteers
- 76 people
- Sponsor
- Ospedale San Donato
Lower Limb, Ischemia
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia
- Conditions
- Lower Limb, Ischemia, Perfusion
- Trial name
- MR CLI (NCT02646150)
- Testing
- Magnetic Resonance Perfusion Imaging
- Where
- South Korea
- Volunteers
- 65 people
- Sponsor
- Seung-Whan Lee, M.D., Ph.D.
Peripheral Arterial Disease
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione.
- Trial name
- CLAUDIA (NCT06774040)
- Testing
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- VivaCell Biotechnology España
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease
The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb Ischemia (CLI), Peripheral Arterial Disease
- Trial name
- DASBAD (NCT07136883)
- Testing
- POBA, Scoring Balloon
- Where
- Spain
- Volunteers
- 83 people
- Sponsor
- Marc Sirvent
Nonrevascularizable Critical Ischemia of the Lower Limbs
Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula.
- Trial name
- HULPVAS (NCT01824069)
- Testing
- Intramuscular injection of a suspension of adult mesenchymal stem cells derived
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Peripheral Artery Disease, Critical Limb Ischemia
Imaging-Guided Vessel Sizing in the Tibial Arteries
This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI).
- Trial name
- iVEST (NCT04748965)
- Testing
- Digital Subtraction Angiography
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Diabetes Mellitus, Critical Limb Ischemia
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Lower Limb Amputation Knee, Peripheral Arterial Disease
- Trial name
- NCT03253328
- Testing
- Active Arm N-acetyl cysteine (NAC)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Washington University School of Medicine
Peripheral Arterial Occlusive Disease, Chronic Limb-Threatening Ischemia
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant [APAC]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed…
- Trial name
- HEALING (NCT07352800)
- Testing
- APAC - dose level 0.50 mg/kg,, Unfractionated heparin (UFH), APAC dose level 1: 0.25 mg/kg,
- Where
- 3 sites in Finland
- Volunteers
- 42 people
- Sponsor
- Aplagon Oy
Critical Limb Ischemia, Arteriosclerosis Obliterans
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury.
- Conditions
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans
- Trial name
- NCT02864654
- Testing
- ADRC injection, ADRC isolation, Liposuction
- Where
- Russia
- Volunteers
- 9 people
- Sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation