Clinical trials: Chronic Lower Limb Ischemia
Lower Limb Ischemia, Peripheral Arterial Disease
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
- Conditions
- Lower Limb Ischemia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Chronic Limb Ischemia
- Trial name
- SupPORT regist (NCT06416644)
- Testing
- Supera Vasculomimetic Stent
- Where
- 15 sites in Portugal
- Volunteers
- 100 people
- Sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
Peripheral Arterial Disease, Critical Limb Ischemia
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- TIC (NCT06544135)
- Testing
- FLIR One Pro LT
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- University Hospitals Cleveland Medical Center
Chronic Limb-threatening Ischemia, Microtia
the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia
Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on…
- Trial name
- MMM (NCT06220994)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
Critical Limb Ischemia
Distal Venous Arterialisation of Ischemic Limb
Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.
- Trial name
- NCT01211925
- Testing
- distal venous arterialisation, Aspirin
- Where
- Serbia
- Volunteers
- 30 people
- Sponsor
- Clinical Centre of Serbia
Lower Limb Ischemia Critical
Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers
The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers.
- Trial name
- NCT05570968
- Testing
- C-arm device
- Volunteers
- 100 people
- Sponsor
- Assiut University
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
Chronic Limb-Threatening Ischemia, Diabetic Foot
Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making
This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to…
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot, Vascular Diseases
- Trial name
- NCT06542523
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
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
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
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The investigators hypothesize that reducing blood viscosity (through controlled phlebotomy), thereby increasing the deformability of red blood…
- Trial name
- CLI-PH (NCT01758874)
- Testing
- phlebotomy
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Seoul Veterans Hospital
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
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions below the knee in symptomatic patients with…
- Trial name
- LIMBO-ATX (NCT02479620)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
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
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
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 Limb Ischemia, Ischemia
VEGF Gene Transfer for Critical Limb Ischemia
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia…
- Conditions
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- Trial name
- NCT00304837
- Testing
- pVGI.1 (VEGF-2)
- Where
- 3 sites in United States
- Sponsor
- Losordo, Douglas, M.D.
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs
Viennese Registry on Patients With Chronic Critical Limb Ischemia
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real…
- Trial name
- NCT01233141
- Where
- Austria
- Volunteers
- 400 people
- Sponsor
- Medical University of Vienna
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
Chronic Lower Limb Ischemia, Peripheral Athero Obstructive Disease
Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery
Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old is 4-22%.
- Conditions
- Chronic Lower Limb Ischemia, Peripheral Athero Obstructive Disease, Critical Ischemia, Claudication
- Trial name
- finnptx (NCT01450722)
- Testing
- bypass surgery, stent placement, stent placement
- Where
- Finland
- Volunteers
- 400 people
- Sponsor
- Kuopio University Hospital
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