Clinical trials: Ischemic Leg
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
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.
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE (NCT04144959)
- Testing
- Indigo Aspiration System
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 119 people
- Sponsor
- Penumbra Inc.
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.
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
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
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
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.
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.
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Diabetic Foot Syndrome
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00537498
- Testing
- Urokinase
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- medac GmbH
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
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
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
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
Non-infected Diabetic Foot Ulcer, Diabetic Foot
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Conditions
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer
- Trial name
- NCT06565156
- Testing
- BR-AM, Standard Care
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- BioStem Technologies
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