Clinical Trials Logo

Clinical Trial Summary

HI-PAD is a placebo controlled double-blind randomized pilot clinical trial to determine whether VM202 may improve walking ability in people with lower extremity peripheral artery disease (PAD).


Clinical Trial Description

The HI-PAD study will randomize 39 people age 55 and older with PAD who do not have critical limb ischemia. The primary outcome is change in the six-minute walk distance at 6-month follow-up after the first study drug injection. A secondary outcome in change in six-minute walk distance at 3-month follow-up. Additional secondary outcomes are pain-free and maximal treadmill walking distance, calf biopsy measures of skeletal muscle regeneration, capillary density, and autophagy, and MRI-measured calf muscle perfusion at three-month follow-up. Investigators will also measure change in six-minute walk distance at 12-month follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03363165
Study type Interventional
Source Northwestern University
Contact
Status Completed
Phase Phase 2
Start date January 1, 2018
Completion date September 5, 2023

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 Systemâ„¢ in Femoropoliteal Arteries N/A
Completed NCT02228564 - BARD® Study of LIFESTREAMâ„¢ 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 NCT02145065 - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r) 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