Clinical trials: Critical Lower Limb Ischemia
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
Critical Leg Ischemia
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al.
- Trial name
- NCT00377897
- Testing
- cell therapy
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University of Paris 5 - Rene Descartes
Intermittent Claudication, Critical Limb Ischemia
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
- Trial name
- NCT00300690
- Testing
- 6 mm Uni-graft® (B-Braun), 6 mm Gore-Tex® (WL Gore)
- Volunteers
- 400 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
Angioplasty, Critical Lower Limb Ischemia
Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia
Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations.
- Trial name
- NCT06127134
- Testing
- peripheral angioplasty for tibial vessels
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Kafrelsheikh University
Critical Limb Ischemia
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications.
- Trial name
- NCT04278014
- Testing
- ultrasound-guided continuous sciatic block with longitudinal approach
- Where
- 2 sites in Colombia
- Volunteers
- 13 people
- Sponsor
- Universidad de Antioquia
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
Critical Limb Ischemia, Diabetic Foot
Autologous Peripheral Blood Mononuclear Cells in Diabetic Foot Patients With No-option Critical Limb Ischemia
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
- Trial name
- NCT04255004
- Testing
- Pall Celeris System, point of care device for human cell therapy
- Volunteers
- 76 people
- Sponsor
- Ospedale San Donato
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), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Critical Limb Ischemia, Arterial Occlusive Disease
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation.
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Vascular Diseases
- Trial name
- SCRIPT-CLI (NCT00913900)
- Testing
- autologous CD133+ cells
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Critical Limb Ischemia
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia.
- Trial name
- NCT00696124
- Testing
- VM202 2 mg, VM202 4 mg, VM202 8 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Critical Lower Limb Ischemia, Type-2 Diabetes Mellitus
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia
The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type…
- Trial name
- DIALEG (NCT01818310)
- Testing
- Group A: Intramuscular, Group B: Intraarterial, Group C: Intravenous
- Where
- Czechia
- Volunteers
- 80 people
- Sponsor
- University Hospital Ostrava
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Patients With Diabetic Foot Syndrome
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00823225
- Testing
- standard therapy, Urokinase
- Where
- 6 sites in Germany
- Volunteers
- 5 people
- Sponsor
- medac GmbH
Critical Limb Ischemia
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as…
- Trial name
- NCT00651885
- Testing
- treprostinil dienthanolmine sustained release
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ochsner Health System
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
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Diabetic Foot, Gangrene; Limb
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor…
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed
- Trial name
- MetaMet (NCT05804565)
- Testing
- Bone Saw, Bone Cutter
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- University College Hospital Galway
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
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer