Hepatocyte Growth Factor to Improve Functioning in PAD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 125 years
- Gender
- Both males and females
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 3-month follow-up after the first study drug injection. A secondary outcome in change in six-minute walk distance at 6-month fo...
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 3-month follow-up after the first study drug injection. A secondary outcome in change in six-minute walk distance at 6-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.
Tracking Information
- NCT #
- NCT03363165
- Collaborators
- National Institute on Aging (NIA)
- Helixmith Co., Ltd.
- Investigators
- Principal Investigator: Mary McDermott, MD Northwestern University
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