The Effects of INP on Peripheral Circulation in Dialysis Patients and Patients With PAD and Leg...
Renal DiseasePeripheral Arterial Disease1 moreThis experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment. The hypothesis of the study is: Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment. Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Peripheral Artery DiseaseFemoropopliteal Artery Stenosis1 moreLong-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
Prime Time for Superficial Femoral Artery (SFA) - The SFA Study
Peripheral Vascular DiseaseThe purpose of this study is to compare the different endovascular treatment modalities for the femoropopliteal segment, and to determine technical success, efficacy and patency at mid-term follow-up. Modalities include; Angioplasty/stent (Control group, Guidant), Cryoplasty/stent (Boston Scientific), Laser Angioplasty/stent (Spectranetics), SilverHawk Atherectomy/stent (Fox Hollow), and Viabahn Endograft (WL Gore).
SIMPADICO - Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication...
Peripheral Arterial DiseaseArterial Occlusive Diseases1 moreThe purpose of this study is to assess the effects of the Celacade™ system in patients with intermittent claudication.
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category...
Peripheral Arterial Disease (PAD)Diabetes Mellitus (DM)6 moreThis trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category...
Peripheral Arterial Disease (PAD)Diabetes Mellitus (DM)6 moreThis trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.
Registry of Cardiovascular Disease Patients
Ischemic Heart DiseaseCongestive Heart Failure4 moreA computerized registry of cardiovascular disease patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify cardiovascular disease patients and to follow the courses of their illnesses and risk factors.
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
Peripheral Arterial DiseaseThis is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
Optimized Supervised Education Program for Peripheral Arterial Disease
Peripheral Arterial DiseasePeripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision...
Peripheral Vascular DiseasesTo 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. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.