Clinical trials: Lower Extremity Arterial Disease
Critical Lower Limb Ischemia, Peripheral Artery Disease
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity…
- Trial name
- PRISTINE (NCT04534257)
- Testing
- SELUTION Sirolimus DCB
- Where
- Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Peripheral Artery Disease
Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
- Trial name
- NCT04197323
- Testing
- Alprostadil liposomes for injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Diabetes Mellitus, Type 2, Intermittent Claudication
Exercise Training for Patients With Poor Leg Circulation
The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and energy supply resulting from calf muscle exercise, and (b) to determine changes in these variables resulting from exercise training…
- Trial name
- NCT00118560
- Testing
- Physical exercise, Physical walking
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Peripheral Artery Disease (PAD)
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become…
- Trial name
- ROXI-PALISADE (NCT07318610)
- Testing
- REGN7508, REGN9933, Rivaroxaban
- Where
- 29 sites in United States, United Kingdom
- Volunteers
- 7,050 people
- Sponsor
- Regeneron Pharmaceuticals
Peripheral Arterial Occlusive Disease, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Lower Limb Ischemia, Peripheral Vascular Diseases
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia.
- Trial name
- RANGER-BTK (NCT02856230)
- Testing
- Ranger SL DEB
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Peripheral Arterial Disease (PAD)
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- UltraFuture I (NCT05498740)
- Testing
- Drug eluting Balloon
- Where
- 24 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Artery Disease
Leg Heat Therapy in Peripheral Artery Disease
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from…
- Trial name
- NCT05465070
- Testing
- Leg heat therapy
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Indiana University
Hypertension, Menopause
The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or…
- Trial name
- NCT03254251
- Testing
- Stair climbing
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pusan National University
Arterial Stiffness, Autonomic Nervous System
Effects of Active Stretching on Cardiovascular Response and Arterial Stiffness in Older Adults With Low Flexibility
A study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability.
- Conditions
- Arterial Stiffness, Autonomic Nervous System, Musculoskeletal Diseases, Range of Motion
- Trial name
- stretching (NCT06944886)
- Testing
- Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)
- Where
- Thailand
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Phayao
Chronic Limb-Threatening Ischemia
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with…
- Trial name
- NCT06421961
- Where
- Sweden
- Volunteers
- 223 people
- Sponsor
- Sahlgrenska University Hospital
Lower Extremity Arterial Disease
Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)
This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.
- Trial name
- NCT05689190
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Diabetic Foot Ulcer Outcome, Quality of Patient Care
The Diabetic Foot Ulcer Registry
This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care.
- Trial name
- DFUR (NCT02813161)
- Testing
- cellular and tissue based therapy, negative pressure wound therapy, debridement
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- U.S. Wound Registry
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
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO).
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Trial name
- VA-ECMO (NCT05830721)
- Testing
- MY01 + Standard of Care, 14-Gauge Slit Catheter + Standard of Care, Standard of Care
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Johns Hopkins University
Peripheral Arterial Disease
Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb
The current treatment approaches for peripheral artery disease are largely unsatisfactory. Therefore, diseased tissue will be collected as well as patient-specific arterial geometries.
- Trial name
- NCT03985150
- Testing
- Biomechanical analysis of femoralis superficialis atherosclerotic tissue, CT or MR angiogram
- Where
- Belgium
- Volunteers
- 31 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Peripheral Arterial Disease(PAD)
Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease
The aim of this study is to investigate the effects of virtual reality exercises on lower extremity skin temperature, arterial stiffness, gait parameters and enjoyment of exercise in individuals with peripheral arterial disease.
- Trial name
- NCT06618131
- Testing
- Exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people
- Sponsor
- Dokuz Eylul University
Peripheral Vascular Diseases, Arterial Occlusive Diseases
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and…
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene
- Trial name
- JUVENTAS (NCT00371371)
- Testing
- Bone marrow punction, BM-MNC infusion
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- UMC Utrecht