Red Light Treatment in Peripheral Artery Disease

Status Recruiting

Clinical Trial Summary

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

Clinical Trial Description

The intent of this protocol is to measure blood flow in the gastrocnemius muscle in patients with documented peripheral artery disease before and after exposure to 670 nm light energy. The study consists of one visit. Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream. Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image. Blood will be drawn to measure nitric oxide metabolites. The study is designed to consist of one visit. However, if the protocol changes or the data quality initially collected is uninterpretable, subjects may be asked to return to allow for a standard methodology across all participants. In this case, the subjects who are asked to return will be subject to the same informed consent process a second time. The two visits will be at least one week apart to further reduce the already minimal risks of the study. This will also limit the number of study participants required to gather the necessary data to complete the study, thereby limiting the risks of the study to a smaller number of participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03203239
Study type	Interventional
Source	University of Alabama at Birmingham
Contact	Nicole L Lohr, MD,PHD
Phone	414-996-3504
Email	nlohr@uabmc.edu
Status	Recruiting
Phase	N/A
Start date	January 17, 2018
Completion date	May 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05712395` - The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease	N/A
Active, not recruiting	`NCT04534257` - 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	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Completed	`NCT02554266` - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed	`NCT03921905` - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting	`NCT06369350` - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion	Early Phase 1
Recruiting	`NCT04545268` - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance	N/A
Recruiting	`NCT02389023` - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery	N/A
Completed	`NCT02563535` - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia	Phase 4
Completed	`NCT02542267` - In-Stent Restenosis Post-Approval Study	N/A
Completed	`NCT02539940` - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed	`NCT02522884` - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries	N/A
Completed	`NCT02145065` - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)	N/A
Completed	`NCT02228564` - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease	N/A
Completed	`NCT02262949` - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System	N/A
Completed	`NCT01743872` - Optical Imaging Measurement of Intravascular Solution Efficacy Trial	N/A
Recruiting	`NCT01424020` - Walking Estimated Limitation Calculated by History - Study 2	Phase 4
Active, not recruiting	`NCT01597453` - NOR-SYS: The Norwegian Stroke in the Young Study	N/A