Clinical trials: Critical Lower Limb Ischaemia
Diabetic Foot, Peripheral Arterial Disease
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- DM PAD (NCT05009602)
- Testing
- Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), Exercise Ankle Brachial Pressure Index (ABPI)
- Where
- 17 sites in United Kingdom
- Volunteers
- 604 people
- Sponsor
- Imperial College London
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
Nonrevascularizable Critical Ischemia of the Lower Limbs
Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula.
- Trial name
- HULPVAS (NCT01824069)
- Testing
- Intramuscular injection of a suspension of adult mesenchymal stem cells derived
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
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
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
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
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
Critical Lower Limb Ischemia
Allografts in Surgery of the Main Arteries
The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive…
- Trial name
- NCT05455138
- Testing
- Arterial bypass grafting
- Where
- Russia
- Volunteers
- 200 people
- Sponsor
- Ryazan State Medical University
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
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.
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
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
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
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.