Clinical trials: Chronic Lower Limb Ischemia
Diabetes Mellitus, Critical Limb Ischemia
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia, Diabetic Foot
- Trial name
- ECAD-CLI (NCT03636867)
- Testing
- data and specimen collection
- Where
- Italy
- Volunteers
- 236 people
- Sponsor
- Maria Cecilia Hospital
Lower Limb Ischaemia
Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)
Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial disease (POAD). Despite progress in the revascularization procedures, half these patients experience amputation or death after one year.
- Trial name
- PREDICCMI (NCT02637492)
- Testing
- Collection of clinical signs and symptoms
- Where
- 3 sites in France
- Volunteers
- 603 people
- Sponsor
- University Hospital, Bordeaux
Peripheral Arterial Disease, Critical Limb Ischemia
Leg Ischaemia Management Collaboration
Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment
- Trial name
- LIMb (NCT04027244)
- Where
- United Kingdom
- Volunteers
- 420 people
- Sponsor
- University of Leicester
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
Lower Limb, Ischemia
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia
- Conditions
- Lower Limb, Ischemia, Perfusion
- Trial name
- MR CLI (NCT02646150)
- Testing
- Magnetic Resonance Perfusion Imaging
- Where
- South Korea
- Volunteers
- 65 people
- Sponsor
- Seung-Whan Lee, M.D., Ph.D.
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
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg.
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer, Infrapopliteal Arterial Occlusive Disease
- Trial name
- NCT07827521
- Testing
- Lower-Extremity Revascularization, Donaperminogene Seltoplasmid
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
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, Peripheral Vascular Disease
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased…
- Trial name
- mesendo (NCT00518401)
- Testing
- Mesendo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
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.
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
Peripheral Vascular Diseases, Ischemia
Autologous Transplantation of Bone Marrow Mononuclear Cell (BM-MNC) With and Without Granulocyte-Colony Stimulation Factor (G-CSF) for Treatment of Chronic Lower Limb Ischemic Patients
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia.
- Trial name
- NCT00677404
- Testing
- BM-MNC injection
- Where
- 2 sites in Iran
- Volunteers
- 20 people
- Sponsor
- Royan Institute
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
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
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system.
- Trial name
- NightHawk (NCT00516308)
- Testing
- NightHawk
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- FoxHollow 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 Vascular Diseases, Hyperglycaemia (Diabetic)
Peripheral Nerve Blocks for Above-the-knee Amputations
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral…
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease
- Trial name
- NCT03404180
- Testing
- Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and…
- Conditions
- Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis, Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity
- Trial name
- NCT07335341
- Testing
- Liberant Thrombectomy System
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular