Clinical trials: Chronic Limb-Threatening Ischemia
Atherosclerotic Ischemic Disease, Critical Limb Ischemia
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal…
- Conditions
- Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04583436
- Testing
- Endovascular recanalization, Open surgery
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Critical Limb Ischemia
Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy
This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia…
- Trial name
- NCT06174597
- Testing
- UCA-PSCs/bFGF or bFGF Intramuscular injection
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Nanjing University
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases
- Trial name
- LEGDEB2 (NCT04175197)
- Testing
- Drug Coated Balloon
- Where
- 7 sites in Italy, Mexico
- Volunteers
- 512 people
- Sponsor
- Federico II University
Buerger Disease, Arteriosclerosis Obliterans
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation.
- Trial name
- NCT00145262
- Testing
- Autologous Bone Marrow Mononuclear Cell Implantation
- Where
- Japan
- Sponsor
- Nagoya University
Critical Limb Ischaemia, Claudication
Peripheral Vascular Disease and Nerve Stimulation
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
- Conditions
- Critical Limb Ischaemia, Claudication, Ulcers, Varicose Veins
- Trial name
- CCLINS (NCT01942941)
- Testing
- geko™ electrical stimulation
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Medium-term Results of Lower Limb Arterial Bypass
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels.
- Conditions
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization, Arterial Bypass Surgery
- Trial name
- MERLLAB (NCT07093632)
- Testing
- Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Hospices Civils de Lyon
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
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
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
Limb Ischemia, Diabetic Foot
Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
- Trial name
- NCT04466007
- Testing
- High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Critical Limb Ischemia, Peripheral Arterial Disease
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a…
- Trial name
- LIMBSAVE (NCT01799811)
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- CryoLife, Inc.
Critical Limb Ischemia, Malnutrition
Nutrition in Patient With Critical Limb Ischemia
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from…
- Conditions
- Critical Limb Ischemia, Malnutrition, Nutritional Supplements
- Trial name
- NutriVasc (NCT03529019)
- Testing
- Ensure Surgery Immunonutrition Shake, Ensure Enlive Advanced Nutrition Shake
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Medical Center
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO).
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Trial name
- VA-ECMO (NCT05830721)
- Testing
- MY01 + Standard of Care, 14-Gauge Slit Catheter + Standard of Care, Standard of Care
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Johns Hopkins University
Critical Limb Ischemia
Distal Venous Arterialisation of Ischemic Limb
Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.
- Trial name
- NCT01211925
- Testing
- distal venous arterialisation, Aspirin
- Where
- Serbia
- Volunteers
- 30 people
- Sponsor
- Clinical Centre of Serbia
Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb…
- Trial name
- CRITISCH (NCT01877252)
- Testing
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- St. Franziskus Hospital
Critical Limb Ischemia, Peripheral Artery Disease
Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions…
- Trial name
- PINNACLE (NCT04534192)
- Testing
- JADE Balloon
- Where
- Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Peripheral Vascular Disease
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb…
- Trial name
- PADI (NCT00471289)
- Testing
- PTA with placement of paclitaxel-eluting stent, PTA
- Where
- 3 sites in Netherlands
- Volunteers
- 144 people
- Sponsor
- Netherlands Society for Interventional Radiology
Critical Limb Ischemia and Peripheral Artery Disease
Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries.
- Trial name
- ACellDREAM2 (NCT03968198)
- Testing
- Autologous ASC (for Adipose-derived Stem/Stroma Cell)
- Where
- France
- Volunteers
- 2 people
- Sponsor
- University Hospital, Toulouse