Clinical trials: Chronic Limb-threatening Ischemia
Peripheral Arterial Disease, Venous Thormboembolism
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures.
- Conditions
- Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases, Vascular Surgery Patient with PAD / Carotid Stenosis
- Trial name
- RESOLUTION (NCT06873321)
- Testing
- rivaroxaban 2.5 mg bid + aspirin 100 mg, clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Science Valley Research Institute
Critical Limb Ischemia (CLI)
Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry
To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal…
- Trial name
- CLEAR TOE (NCT07014072)
- Testing
- intensive toe pressure evaluation, data collection
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bordeaux
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
Critical Limb Ischemia
Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of autologous bone marrow-derived MSCs. Following informed consent, patients who meet the criteria will be screened and enrolled.
- Trial name
- NCT03455335
- Testing
- 20 million hMSCs, 40 million hMSCs, 80 million hMSCs
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- National University of Ireland, Galway, Ireland
Chronic Limb Threatening Ischemia
Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of…
- Trial name
- NCT07120555
- Testing
- atherectomy, Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Critical Limb Ischemia, Claudication, Intermittent
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound…
- Trial name
- PAT (NCT06007469)
- Volunteers
- 50 people
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
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
Diabetic Foot
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia
Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial.
- Trial name
- NCT01065337
- Testing
- tissue repair cells (TRC), bone marrow stem cells (BMC)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Ruhr University of Bochum
Critical Limb Ischemia
Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy…
- Trial name
- NCT04661644
- Testing
- Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial), Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- S.Biomedics Co., Ltd.
Critical Limb Ischemia
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon…
- Trial name
- DEBATE-BTK (NCT01558505)
- Testing
- PEB, POBA
- Where
- Italy
- Volunteers
- 142 people
- Sponsor
- Leonardo Bolognese, MD
Ischemia, Peripheral Arterial Disease
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Conditions
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Trial name
- NCT02044666
- Testing
- Micronized Small Intestinal Submucosa (SIS)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cook Group Incorporated
Peripheral Vascular Diseases, Peripheral Arterial Disease
Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional…
- Conditions
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
- Trial name
- MSOT_IC (NCT05373927)
- Testing
- Multispectral Optoacoustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ulrich Rother
Critical Limb Ischemia
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.
- Trial name
- NCT03680105
- Testing
- RJX
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Reven Pharmaceuticals, Inc.
Chronic Limb-Threatening Ischemia
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with…
- Trial name
- NCT06421961
- Where
- Sweden
- Volunteers
- 223 people
- Sponsor
- Sahlgrenska University Hospital
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
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Peripheral Arterial Disease
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when…
- Trial name
- NCT02915796
- Testing
- G-CSF + CD133(+) cells, G-CSF, percutaneous transluminal angioplasty (PTA)
- Where
- China
- Volunteers
- 345 people
- Sponsor
- Shanghai 10th People's Hospital
Intermittent Claudication, Peripheral Vascular Diseases
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia
The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg…
- Trial name
- ABC (NCT00539266)
- Testing
- bone marrow derived mononuclear cells
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- Leiden University Medical Center
Peripheral Artery Disease
Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization
Sortilin is a 95-kDa protein related to circulating cholesterol. It is found inside different cell types and circulating in blood and it has been associated with the risk of atherosclerosis development and cardiovascular…
- Trial name
- NCT05759130
- Where
- Italy
- Volunteers
- 207 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS