Clinical trials: Chronic Limb-threatening Ischemia
Diabetic Foot, Critical Limb Ischemia
Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia
In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the…
- Trial name
- August2 (NCT01638585)
- Testing
- urokinase
- Where
- 18 sites in Germany
- Volunteers
- 34 people
- Sponsor
- GWT-TUD GmbH
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Lower Limb Ischemia, Peripheral Vascular Diseases
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia.
- Trial name
- RANGER-BTK (NCT02856230)
- Testing
- Ranger SL DEB
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Critical Limb Ischemia
Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following…
- Trial name
- DISAPEAR (NCT02043795)
- Testing
- BVS, Abbott Vascular
- Where
- Singapore
- Volunteers
- 15 people
- Sponsor
- Changi General Hospital
Lower Limb Ischemia
Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated…
- Trial name
- NCT05569369
- Testing
- angioplasty and stenting
- Volunteers
- 25 people
- Sponsor
- Sohag University
Critical Limb Ischemia
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
The investigators designed a randomized clinical trial (stem cell emergency life threatening arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of enriched circulating EPCs (ECEPCs) with…
- Trial name
- SCELTA (NCT02454231)
- Testing
- Transplantation of circulating CD14+CD34+cells, Transplantation of BM MNC
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- University of Florence
Critical Lower Limb Ischemia
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
- Trial name
- NCT04490408
- Testing
- long surgical bypass, Hybrid approach
- Volunteers
- 52 people
- Sponsor
- Egyptian Biomedical Research Network
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
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
Peripheral Arterial Disease
Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter…
- Trial name
- BIBLIOS (NCT03845543)
- Testing
- Luminor-14 Paclitaxel eluting balloon
- Where
- 9 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- ID3 Medical
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
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
Peripheral Arterial Disease, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
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
Thromboangiitis Obliterans, Arteritis
Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia
- Conditions
- Thromboangiitis Obliterans, Arteritis, Peripheral Arterial Disease
- Trial name
- NCT02089828
- Testing
- autologous purified CD34+ cells, autologous peripheral blood mononuclear cells
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Zhongshan Hospital
Critical Limb Ischemia, Peripheral Artery Disease
Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions…
- Trial name
- PINNACLE (NCT04534192)
- Testing
- JADE Balloon
- Where
- Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Critical Limb Ischemia
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated.
- Trial name
- NCT00760357
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Southwest Regional Wound Care Center
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
GLASS Classification and CLTI
Critical limb threatening ischemia "CLTI 'is not a separate local disease but also it is a part of generalized vascular disorder.
- Trial name
- NCT05209672
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Assiut University
Chronic Limb-Threatening Ischemia
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
- Trial name
- HEAL-SCS (NCT05322798)
- Testing
- High-frequency SCS, Low-frequency SCS
- Where
- Russia
- Volunteers
- 25 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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