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53 active trials for Critical Limb Ischemia

Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)

A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).

Start: November 2017

Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.

The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.

Start: April 2020

Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)

Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is associated with increased risk of cardiovascular death, myocardial infarction (MI), stroke and amputation. Feringa et al. demonstrated in a study of 1,374 patients with PAD that all cause and cardiac related mortality rates were lower in patients at higher statin dose and lower levels of low-density lipoprotein cholesterol (LDL). Patients with CLI statin therapy and lower LDL levels improve amputation-free survival and patency after revascularization procedures. In the FOURIER trial, LDL cholesterol reduction with the PCSK9 inhibitor evolocumab in patients with symptomatic PAD with or without prior myocardial infarction or stroke was associated with improved major adverse cardiac events (MACE) and major adverse limb events (MALE) at 2-years. The effect of evolocumab in patients with CLI , after a recent arterial revascularization and active wounds is not known, also it is not known whether the cholesterol lowering effect of evolocumab in this group of patients is equivalent to that of non-CLI PAD patients and what the effect is on arterial perfusion, wound healing and other biological markers of vascular physiology. This study aims to investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization.

Start: February 2020

Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)

Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.

Start: January 2017

ACP-01 in Patients With Critical Limb Ischemia

The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.

Start: August 2014

LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

Start: November 2019

Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT

Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI). This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse the development of the pathology of CLI. It is expected to have a direct consequence on function and quality of life in patients with Peripheral artery disease (PAD); in this case a subgroup of patients with CLI, the worst presentation of PAD.

Start: September 2019

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Start: June 2017

Cell Therapy in Critical Limb Ischemia

Study drug and dosage form : Umbilical cord-derived mesenchymal stem cells (HB-MSC1) Dose and route of administration : 60 × 106 cells or 120 x 106 cells to be injected as 30 individual intramuscular injections, once at V0 within 48 hours to 2 weeks maximum after the revascularization procedure. Comparator, dose and route of administration : Placebo, injected as 30 individual intramuscular injections, once at V2 within 48 hours to 2 weeks maximum after the revascularization procedure. Study centers : 3 centers in France Study objectives : Primary: Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI). Secondary: Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms. Exploratory: Constitution of a serum bank of the patients included in the study for inflammation and auto immunity biomarkers analysis Study design : This will be a multicenter Phase IIa study, consisting in a first, open-label, ascending dose feasibility and safety stage followed by a randomized placebo-controlled feasibility, safety and preliminary efficacy stage.

Start: September 2019

Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)

Prospective, randomized, controlled, multi-center study A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria. Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin, clopidogrel) A group, or DAP (aspirin, cilostazol) B group. All patients will be treated with angioplasty for critical limb ischemia. Patients will be followed clinically for 1 year after the procedure. Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Start: February 2017

Treatment of No-option CLI by G-CSF-mobilized PB-MNC

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

Start: October 2018

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 patients with diabetes mellitus and critical limb ischemia.

Start: August 2018

Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease

Start: January 2020