Clinical trials: Chronic Limb-threatening Ischemia
Critical Limb Ischemia, Peripheral Arterial Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Major Adverse Limb Events, Major Adverse Cardiovascular Events
Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage
Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades.
- Conditions
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- TAMIS (NCT06318767)
- Testing
- hemodynamic measure of the Systolic Time Rise
- Where
- France
- Volunteers
- 134 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Peripheral Arterial Disease, Critical Limb Ischemia
ACPs in Severe PAD/CLI by Direct Intramuscular Injection
Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D.
- Trial name
- NCT00523731
- Testing
- Angiogenic Cell Precursors (ACPs) or Vescell TM
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- TheraVitae Ltd.
Peripheral Arterial Disease, Critical Limb Ischemia
The PRELUDE BTK Study
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
- Trial name
- NCT03693963
- Testing
- Serranator
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Cagent Vascular LLC
Obstructive Coronary Artery Disease
Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia
The objective of the INCORPORATE trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a…
- Trial name
- INCORPORATE (NCT03712644)
- Testing
- FFR-guided coronary revascularization
- Where
- 2 sites in Austria, Hungary
- Volunteers
- 650 people
- Sponsor
- Medical University of Graz
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Peripheral Arterial Disease
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.
- Trial name
- CURRENT (NCT05701293)
- Testing
- Endovascular implantation of Renzan Stent
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliera Universitaria Senese
Critical Limb Ischemia, Arterial Occlusive Disease
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation.
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Vascular Diseases
- Trial name
- SCRIPT-CLI (NCT00913900)
- Testing
- autologous CD133+ cells
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Limb Ischemia
Nanofat Grafting as a Method of Treating Critical Limb Ischemia
This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior…
- Trial name
- NCT06357936
- Testing
- nano-fat grafting in chronic limb ischaemia
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Center of New Medical Technologies
Peripheral Arterial Disease
Use of Indocyanine Green Angiography in Critical Limb Ischemia
Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with…
- Trial name
- FLUORESCENCE (NCT02820467)
- Testing
- fluorescence angiography
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Grenoble
Diabetes Mellitus, Critical Limb Ischemia
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia, Diabetic Foot
- Trial name
- ECAD-CLI (NCT03636867)
- Testing
- data and specimen collection
- Where
- Italy
- Volunteers
- 236 people
- Sponsor
- Maria Cecilia Hospital
Diabetic Foot, Peripheral Arterial Disease
Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients
Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of clinical examination, medical history and…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Ischaemic Neuropathy
- Trial name
- NCT03002116
- Testing
- Tissue thermometry using non-invasive microwave radiometry device
- Where
- 3 sites in Greece, United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Attikon Hospital
Peripheral Arterial Disease, Critical Limb Ischemia
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- TIC (NCT06544135)
- Testing
- FLIR One Pro LT
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- University Hospitals Cleveland Medical Center
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Critical Limb Ischemia, Drug Effect
Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization.
- Trial name
- DebateBTKDuell (NCT04594889)
- Testing
- angioplasty
- Where
- Italy
- Volunteers
- 170 people
- Sponsor
- Ospedale San Donato
Critical Limb Ischemia, Peripheral Arterial Disease
Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease
- Trial name
- RESTORE (NCT03041259)
- Testing
- Rejuveinix Low Dose, Rejuveinix High Dose
- Volunteers
- 320 people
- Sponsor
- Reven Pharmaceuticals, Inc.
Critical Limb Ischemia
Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia.
- Trial name
- CLI-DI (NCT02234778)
- Testing
- TGI SVF material via intramuscular injection
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Tissue Genesis
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, Atherosclerosis
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
- Conditions
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
- Trial name
- NCT01833585
- Testing
- Peripheral blood mononuclear cell
- Where
- Thailand
- Volunteers
- 8 people
- Sponsor
- Mahidol University
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.