Clinical trials: Lower Extremity Arterial Disease
Peripheral Artery Disease
Leg Thermotherapy for Intermittent Claudication
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication.
- Trial name
- NCT02770547
- Testing
- Low Heat Thermotherapy, High Heat Thermotherapy
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Indiana University
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 Arterial Disease
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
- Trial name
- NCT02653456
- Testing
- RA-308 Excimer Laser and DABRA Catheter
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ra Medical Systems
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Intermittent Claudication, Peripheral Vascular Disease
Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.
- Conditions
- Intermittent Claudication, Peripheral Vascular Disease, Lower Limb Arterial Disease
- Trial name
- AdjIC (NCT02429310)
- Testing
- Revitive IX
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Imperial College London
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Amputation, Diabetes Mellitus
Dysvascular Amputation Self-Management of Health
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Trial name
- DASH (NCT04083456)
- Testing
- Walking Biobehavioral Intervention, Attention Control
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Colorado, Denver
Peripheral Artery Disease
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.
- Trial name
- REVEAL (NCT02961894)
- Testing
- Revolution™ Peripheral Atherectomy System
- Where
- 17 sites in United States
- Volunteers
- 121 people
- Sponsor
- Rex Medical
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
Atherosclerosis of Native Arteries of the Extremities, Unspecified
SuperNOVA Clinical Stenting Trial
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
- Trial name
- NCT01292928
- Testing
- Stent implantation
- Where
- 49 sites in United States, Austria and 5 more
- Volunteers
- 299 people
- Sponsor
- Boston Scientific Corporation
Peripheral Artery Disease
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality…
- Trial name
- OPTIMISE (NCT01743872)
- Testing
- Contrast Injection, Dextran Injection, CO2 Injection
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Peripheral Arterial Disease
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits.
- Trial name
- NCT00687076
- Testing
- Ezetimibe, Niaspan, Statin therapy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Baylor College of Medicine
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Diabetes, Diabetic Foot Ulcer
Electrical Stimulation to Accelerate Wound Healing
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed…
- Conditions
- Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy, Peripheral Arterial Disease
- Trial name
- NCT03821675
- Testing
- Electrical Stimulation - Active
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Baylor College of Medicine
Peripheral Arterial Disease (PAD)
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
- Trial name
- WISE-LE (NCT02780349)
- Testing
- WIRION
- Where
- 10 sites in United States, Germany
- Volunteers
- 103 people
- Sponsor
- Gardia Medical
Diabetic Foot Ulcer
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial…
- Trial name
- NCT00765063
- Testing
- Fragmin
- Where
- 27 sites in Austria, Belgium and 12 more
- Volunteers
- 62 people
- Sponsor
- Pfizer
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Type 2 Diabetes, Peripheral Arterial Disease
Liraglutide and Peripheral Artery Disease
STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with…
- Trial name
- STARDUST (NCT04881110)
- Testing
- Liraglutide, Control
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University of Campania Luigi Vanvitelli
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.