Clinical trials: Critical Ischemia Limb
Peripheral Arterial Disease
Gut Microbiota in Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia
Microbiota has been associated with risk factors for cardiovascular diseases (hypertension, obesity, dyslipidemia, diabetes mellitus, heart failure).
- Trial name
- NCT05757297
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
The ROAMM-EHR Study
In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes.
- Trial name
- ROAMM-EHR (NCT06263322)
- Testing
- Actionable remotely generated health data, Non-Actionable remotely generated health data
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Florida
Arterial Occlusive Diseases, Vascular Diseases
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass.
- Trial name
- SPACIAL (NCT01147419)
- Testing
- stent, femoral-popliteal bypass with artificial blood vessel
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
Peripheral Arterial Disease
Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
The primary aim of this trial was to investigate the safety of a 6 hour intraarterial infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive disease (PAOD) and chronic Critical Limb Ischaemia…
- Trial name
- COINART-1 (NCT02215824)
- Testing
- BIWH 3
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
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
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
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
- Trial name
- BEST-CLI (NCT02060630)
- Testing
- Open surgical revascularization, Endovascular revascularization
- Where
- 161 sites in United States, Canada and 3 more
- Volunteers
- 1,843 people
- Sponsor
- Carelon Research
Peripheral Arterial Disease (PAD), Claudication, Intermittent
Expression of GLP1 Receptor on Peripheral Blood Mononuclear Cells in Advanced Peripheral Artery Disease: Paving the Way for GLP1R Agonists Treatment in Chronic Limb Threatening Ischemia
The goal of this observational study is to learn whether activation of the GLP-1 receptor could represent a therapeutic target by characterizing its expression and associated inflammatory mechanisms in patients with peripheral…
- Conditions
- Peripheral Arterial Disease (PAD), Claudication, Intermittent, Chronic Limb-Threatening Ischemia
- Trial name
- EXCEL-CLTI (NCT07340112)
- Testing
- Analysis of GLP-1 receptor expression
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Critical Limb Ischemia (CLI)
Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor…
- Trial name
- NCT01408381
- Testing
- Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells
- Where
- 5 sites in Spain
- Volunteers
- 38 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Diabetes, Wounds
Plerixafor in Diabetic Wound Healing
Chronic non-healing wounds represent a major source of morbidity, disability, and mortality in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations worldwide.
- Conditions
- Diabetes, Wounds, Critical Limb Ischemia
- Trial name
- MOZOBL07740 (NCT02790957)
- Testing
- Plerixafor
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Gian Paolo Fadini
Critical Limb Ischemia
UT-15C SR in the Treatment of Critical Limb Ischemia
This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease.
- Trial name
- NCT00445159
- Testing
- UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Southern Arizona Vascular Institute
Peripheral Vascular Disease
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia…
- Trial name
- NCT00067041
- Testing
- Remodulin (treprostinil sodium) Injection
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective.
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Buerger's Disease
- Trial name
- NCT01446055
- Testing
- ResQ processed bone marrow sample, Ficoll conventional cell processing method
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xuanwu Hospital, Beijing
Chronic Critical Ischemia
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast.
- Trial name
- ELIT (NCT01634815)
- Testing
- The Edge
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Strasbourg, France
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
Peripheral Vascular Disease, Peripheral Arterial Disease
Muscle Perfusion in Patients With PAD by Non-invasive MSOT
The aim of the proposed study is to define an independent parameter for the diagnostic assessment of the perfusion situation of the calf muscle based on Multispectral Optoacoustic Tomography (MSOT) in a cross-sectional collective…
- Trial name
- NCT04641091
- Testing
- Multispectral Optoacustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- University Hospital Erlangen
Peripheral Vascular Diseases
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based…
- Trial name
- NCT01558908
- Testing
- Administration of ERC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Medistem Inc.
Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural…
- Trial name
- CALCIO (NCT06149650)
- Testing
- Shockwave Medical IVL System
- Where
- 39 sites in Austria, Canada and 6 more
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe