Clinical trials: Critical Lower Limb Ischemia
Critical Limb Ischemia
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular…
- Trial name
- ArtAssist (NCT02054416)
- Testing
- ArtAssist© Device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Temple University
Peripheral Vascular Disease, Diabetic Foot
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes.
- Conditions
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease, Leg Ulcer
- Trial name
- BONMOT (NCT00434616)
- Testing
- Autologous bone marrow cell concentrate transplantation, saline injection
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Franziskus-Krankenhaus
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
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
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
Peripheral Vascular Diseases, Arterial Occlusive Diseases
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and…
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene
- Trial name
- JUVENTAS (NCT00371371)
- Testing
- Bone marrow punction, BM-MNC infusion
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- UMC Utrecht
Vascular Disease, Critical Lower Limb Ischemia
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
- Trial name
- NCT00633659
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Sangart
Angioplasty, Anaesthesia and Analgesia
Popliteal Block for Lower Limb Angioplasty
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients.
- Trial name
- NCT04445480
- Testing
- Popliteal block, Control
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
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
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.
- Trial name
- NCT01861327
- Testing
- CO2, Iodine contrast media
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Nelson Wolosker
Type 2 Diabetes Mellitus, Diabetic Foot
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding…
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Foot, Critical Limb Ischemia
- Trial name
- August-1 (NCT01599442)
- Where
- Germany
- Volunteers
- 123 people
- Sponsor
- GWT-TUD GmbH
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial…
- Trial name
- ERAV (NCT05101512)
- Testing
- Questionnaires on quality of life after surgery
- Where
- France
- Volunteers
- 150 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Peripheral Vascular Disease, Critical Limb Ischemia
Drug Eluting Stents In The Critically Ischemic Lower Leg
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia.
- Trial name
- DESTINY (NCT00510393)
- Testing
- XIENCE V everolimus eluting coronary stent system, MULTILINK VISION coronary stent system
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 140 people
- Sponsor
- Flanders Medical Research Program
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Critical Lower Limb Ischemia, Peripheral Artery Disease
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity…
- Trial name
- PRISTINE (NCT04534257)
- Testing
- SELUTION Sirolimus DCB
- Where
- Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Peripheral Arterial Occlusive Disease, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
- Conditions
- Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot
- Trial name
- PiPER (NCT06277362)
- Where
- 9 sites in Italy
- Volunteers
- 50 people
- Sponsor
- EndoCore Lab s.r.l.