Clinical trials: Critical Limb-Threatening Ischemia
Critical Limb Ischemia
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
- Trial name
- LOA (NCT00767923)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HyperMed
Critical Limb Ischemia
SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)
Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are…
- Trial name
- SCOPE CLI (NCT03171259)
- Testing
- care as usual
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Saint Luke's Health System
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
Critical Lower Limb Ischemia, Critical Limb Ischemia
Evaluation of Carbothera in the Treatment of Foot Ulcers
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease.
- Conditions
- Critical Lower Limb Ischemia, Critical Limb Ischemia, Foot Ulcer, Skin Ulceration
- Trial name
- NCT02239419
- Testing
- CO2-Enriched Tap Water (Carbothera), Non-CO2-Enriched Tap Water
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Manitoba
Peripheral Arterial Disease, Claudication
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT02475200
- Testing
- Atherectomy
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
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
Peripheral Arterial Disease
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise…
- Trial name
- NCT00224328
- Testing
- ODISsey Tissue Oximeter
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- ViOptix Canada
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
Peripheral Arterial Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter…
- Trial name
- TOBA II BTK (NCT02942966)
- Testing
- Tack Endovascular System
- Where
- 49 sites in United States, Austria and 4 more
- Volunteers
- 233 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia
Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia
The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral…
- Trial name
- NCT01019681
- Testing
- Cord blood stem cell injection
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Richard Burt, MD
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
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
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation.
- Trial name
- NCT02145897
- Testing
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Atherosclerotic Ischemic Disease, Critical Limb Ischemia
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal…
- Conditions
- Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04583436
- Testing
- Endovascular recanalization, Open surgery
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Critical Limb Ischemia
Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy
This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia…
- Trial name
- NCT06174597
- Testing
- UCA-PSCs/bFGF or bFGF Intramuscular injection
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Nanjing University
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
Buerger Disease, Arteriosclerosis Obliterans
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation.
- Trial name
- NCT00145262
- Testing
- Autologous Bone Marrow Mononuclear Cell Implantation
- Where
- Japan
- Sponsor
- Nagoya University
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, Critical Limb Ischemia
Medium-term Results of Lower Limb Arterial Bypass
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels.
- Conditions
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization, Arterial Bypass Surgery
- Trial name
- MERLLAB (NCT07093632)
- Testing
- Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Hospices Civils de Lyon