Clinical trials: Critical Ischemia Limb
Arterial Occlusive Disease, Peripheral Vascular Disease
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers
The objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and…
- Conditions
- Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia, Ulcers
- Trial name
- NCT00189540
- Testing
- HGF plasmid
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- AnGes USA, Inc.
Chronic Limb-Threatening Ischemia, Diabetic Foot
Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making
This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to…
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot, Vascular Diseases
- Trial name
- NCT06542523
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
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
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.
Arteriosclerosis, Peripheral Artery Disease
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening…
- Conditions
- Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia
- Trial name
- Act (NCT05620095)
- Testing
- drug-coated balloon
- Where
- 10 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Peripheral Vascular Diseases, Arterial Occlusive Diseases
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and…
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene
- Trial name
- JUVENTAS (NCT00371371)
- Testing
- Bone marrow punction, BM-MNC infusion
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- UMC Utrecht
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2)
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
- Conditions
- Arterial Occlusive Disease, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04274049
- Testing
- NL003, Normal Saline
- Where
- 21 sites in China
- Volunteers
- 242 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Peripheral Arterial Disease, Intermittent Claudication
Heat Therapy for Peripheral Arterial Disease (HEATPAD)
Peripheral arterial disease (PAD) is a disabling condition, with symptoms of muscle cramping or pain on exertion, which can substantially reduce quality of life.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- HEATPAD (NCT06186505)
- Testing
- AirGlove
- Volunteers
- healthy volunteers welcome
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Critical Limb Ischemia (CLI), Diabetes
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs…
- Trial name
- NCT01257776
- Testing
- Autologous adipose derived mesenchymal stem cells
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Chronic Threatening Lower Limb Ischemia
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the…
- Trial name
- DUS-CTA (NCT07113197)
- Testing
- conventional angiography
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University
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
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
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
Infrapopliteal Lesions, Critical Limb Ischemia
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with…
- Trial name
- NCT05971394
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Peripheral Vascular Diseases
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system.
- Trial name
- NightHawk (NCT00516308)
- Testing
- NightHawk
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- FoxHollow Technologies
Critical Limb Ischemia
YQ23 Study in Patients With Critical Limb Ischaemia
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia.
- Trial name
- YAN (NCT04792008)
- Testing
- YQ23
- Where
- 2 sites in Hong Kong
- Volunteers
- 5 people
- Sponsor
- New Beta Innovation Limited
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
Chronic Limb-Threatening Ischemia, Surgery-Complications
Use of CPETarm for Risk Stratification of Patients With CLTI
This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer.
- Trial name
- NCT06404229
- Testing
- CardioPulmonary Exercise Testing
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- University of Manchester
Critical Limb Ischemia, Extracellular Matrix Alteration
Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization
In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.
- Conditions
- Critical Limb Ischemia, Extracellular Matrix Alteration, Peripheral Revascularisation
- Trial name
- ROMAMETA (NCT02388867)
- Testing
- Polytetrafluoroethylene (PTFE) bypass grafting., Autogenous vein bypass grafting
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics