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Intermittent Claudication clinical trials

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NCT ID: NCT05191862 Terminated - Clinical trials for Intermittent Claudication

Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

Start date: April 23, 2022
Phase: Phase 1
Study type: Interventional

The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.

NCT ID: NCT04100681 Terminated - Clinical trials for Critical Limb Ischemia

Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication

FlowOx
Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.

NCT ID: NCT02374957 Terminated - Clinical trials for Peripheral Arterial Disease

Cilostazol After Lower Extremity Arterial Revascularization Trial

CLEAR
Start date: February 2015
Phase: Phase 4
Study type: Interventional

Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of Cilostazol versus usual care without Cilostazol and its effect on quality of life.

NCT ID: NCT02373462 Terminated - Clinical trials for Peripheral Artery Disease With Intermittent Claudication

Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

Start date: August 25, 2015
Phase: Phase 4
Study type: Interventional

To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

NCT ID: NCT02152930 Terminated - Clinical trials for Intermittent Claudication

The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

FISHTIC
Start date: December 2014
Phase: Phase 3
Study type: Interventional

Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis. We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.

NCT ID: NCT02086331 Terminated - Clinical trials for Standardised Claudication Treadmill Test

Evaluation of Musculoskeletal Microcirculation With Ultrasound

EMMU
Start date: December 2013
Phase: N/A
Study type: Interventional

This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.

NCT ID: NCT01808989 Terminated - Claudication Clinical Trials

Clinical Interest of the TcPO2 Technique

CINEYSOFT
Start date: November 2013
Phase:
Study type: Observational

The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded. The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

NCT ID: NCT01799057 Terminated - Clinical trials for Peripheral Arterial Disease

The Effects of Metformin on Functional Capacity in Individuals With Peripheral Artery Disease-Related Intermittent Claudication

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effects of metformin on functional capacity (pain-free and maximum walking times) in individuals with peripheral artery disease (PAD)-related intermittent claudication.

NCT ID: NCT01731990 Terminated - Clinical trials for Peripheral Artery Disease

Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

Start date: October 30, 2012
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

NCT ID: NCT01385774 Terminated - Clinical trials for Peripheral Arterial Disease

SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.

SUPER
Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA. It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.