Clinical trials: Critical Lower Limb Ischaemia
Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial…
- Trial name
- ERAV (NCT05101512)
- Testing
- Questionnaires on quality of life after surgery
- Where
- France
- Volunteers
- 150 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Peripheral Arterial Disease, Leg Ulcer
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation.
- Trial name
- NCT06326203
- Testing
- CELULAS TRONCO, CONVENTIONAL DRESSING
- Volunteers
- 40 people
- Sponsor
- UPECLIN HC FM Botucatu Unesp
Critical Limb Ischemia (CLI), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Critical Lower Limb Ischemia, Type-2 Diabetes Mellitus
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia
The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type…
- Trial name
- DIALEG (NCT01818310)
- Testing
- Group A: Intramuscular, Group B: Intraarterial, Group C: Intravenous
- Where
- Czechia
- Volunteers
- 80 people
- Sponsor
- University Hospital Ostrava
Critical Limb Ischemia, Peripheral Arterial Disease - PAD
Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial occlusive disease.CLI is…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease - PAD, Ischemic Ulcer, Ischemic Feet
- Trial name
- NCT04746599
- Testing
- Autologous Fat Grafting
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Critical Limb Ischemia (CLI)
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
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the…
- Trial name
- NCT02287974
- Testing
- Stem cell infusion
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Critical Lower Limb Ischemia, Postoperative Complications
Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
The peripheral arterial disease (PAD) has been associated with all-cause and cardiovascular mortality. Despite minimally invasive endovascular techniques, patients with critical limb-threatening ischemia (CLTI) have a poor…
- Trial name
- NCT04756115
- Testing
- Vascular Surgery.
- Where
- Spain
- Volunteers
- 310 people
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Critical Limb Ischemia, Arterial Occlusive Disease
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these…
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Pain, Ischemia
- Trial name
- NCT00403780
- Testing
- pregabalin
- Where
- 3 sites in Sweden
- Volunteers
- 18 people
- Sponsor
- Karolinska Institutet
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
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, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
Critical Limb Ischemia
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications.
- Trial name
- NCT04278014
- Testing
- ultrasound-guided continuous sciatic block with longitudinal approach
- Where
- 2 sites in Colombia
- Volunteers
- 13 people
- Sponsor
- Universidad de Antioquia
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
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
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Critical Limb-Threatening Ischemia, Critical Limb Ischemia
Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Conditions
- Critical Limb-Threatening Ischemia, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- MAGNITUDE-BTK (NCT06075940)
- Testing
- MAGNITUDE BRS
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Abdominal Aortic Aneurysm, Carotid Atherosclerosis
Preconditioning Shields Against Vascular Events in Surgery
Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels.
- Conditions
- Abdominal Aortic Aneurysm, Carotid Atherosclerosis, Critical Lower Limb Ischaemia
- Trial name
- SAVES (NCT01691911)
- Testing
- Remote preconditioning
- Where
- Ireland
- Volunteers
- 200 people
- Sponsor
- Mid Western Regional Hospital, Ireland
Lower Extremity Ischemia, Leg Ulcer
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
- Conditions
- Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease, Diabetic Foot
- Trial name
- NCT01903044
- Testing
- BM-MNC injection
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Pontifícia Universidade Católica do Paraná