Clinical trials: Lower Extremity Ischemia
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
Arterial Leg Ulcer
Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
The main objective of this trial is to study the healing effect of an oral drug (isoniazid) in patients with ischemic (arterial) leg ulcers defined by a systolic toe pressure <40 mm Hg.
- Trial name
- SONIA (NCT04802928)
- Testing
- Isoniazid 300 milligram
- Where
- Denmark
- Sponsor
- Pharma 2100
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
Lower Limb Ischemia
Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis.
- Trial name
- TGI-PVG-IDE (NCT01305863)
- Testing
- ASC coated ePTFE vascular graft, Propaten graft
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Tissue Genesis
Peripheral Arterial Disease, Atherosclerotic Lesion
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral…
- Conditions
- Peripheral Arterial Disease, Atherosclerotic Lesion, Lower Extremity Ischemia, Lower Extremity Claudication
- Trial name
- RESOLV I (NCT04912323)
- Testing
- Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
- Where
- 7 sites in Austria, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
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
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Peripheral Vascular Disease
Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within…
- Trial name
- NCT00053716
- Testing
- Liprostin [liposomal Prostaglandin E1]
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Endovasc
Critical Limb Ischemia, Severe Leg Ischemia
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of…
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Trial name
- MESENDO (NCT00721006)
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- TCA Cellular Therapy
Lower Limb Ischaemia
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or…
- Trial name
- NCT07891208
- Testing
- Nasal high flow oxygen
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Acute Peripheral Arterial Occlusion
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion.
- Trial name
- NCT01222117
- Testing
- Plasmin, Plasminogen Activator
- Where
- 39 sites in United States, Belgium and 10 more
- Volunteers
- 174 people
- Sponsor
- Grifols Therapeutics LLC
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
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
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 Arterial Disease
Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia
The primary objective of the Phase I ascending dose trial is to investigate the safety and tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product, CTX, in patients with peripheral arterial…
- Trial name
- NCT01916369
- Testing
- CTX DP
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- ReNeuron Limited
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
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.
Percutaneous Transluminal Angioplasty, Atherosclerosis of Arteries of the Extremities, Unspecified
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal…
- Trial name
- SMILLA (NCT07312383)
- Testing
- Examination with the ODI-Tech medical device
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ODI Medical AS