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COMPLETEDPHASE2

Hepatocyte Growth Factor to Improve Functioning in PAD

Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study

NCT03363165•Northwestern University

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).

Detailed 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.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 55 or above
•Symptomatic PAD, defined as exertion-induced ischemic calf muscle symptoms during the six-minute walk, during the baseline exercise stress test, or during daily walking activities. PAD will be defined as an ankle brachial index (ABI) \< or = 0.90 at the baseline study visit or vascular lab evidence of PAD or angiographic evidence of significant PAD.
•Evidence of proliferative retinopathy. Participants who were treated for retinopathy at least 5 years prior to their baseline assessment who do not have evidence of proliferative retinopathy at the time of baseline assessment may still be eligible.
•Positive test for active Human Immunodeficiency Virus (HIV), hepatitis B virus, hepatitis C virus or Human T-lymphotropic virus. Patients who have positive antibodies for HIV, hepatitis B, or hepatitis C who do not have detectable viral load will be eligible for participation.
•Mini-Mental Status Examination (MMSE) score \<23 or dementia.
•Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
•Increase in angina or angina at rest.
•Premenopausal women.
•Non-English speaking.
•Visual impairment that limits walking ability.
+6 more criteria

Exclusion Criteria

•Above- or below-knee amputation.
•Critical limb ischemia, including individuals with gangrene and lower extremity ulcers.
•Wheelchair-bound or requiring a cane or walker to ambulate.
•Walking is limited by a symptom other than PAD.
•Lower extremity revascularization, orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months and planned revascularization or major surgery during the next six months.
•Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months. \[NOTE: Participants who only use oxygen at night may still qualify\]

Locations (1)

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

January 1, 2018

Primary Completion Date

February 10, 2023

Completion Date

September 5, 2023

Last Updated

May 30, 2024

Enrollment

ACTUAL participants

Conditions

Peripheral Artery Disease

Interventions

VM202

DRUG

Placebo

OTHER

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Hepatocyte Growth Factor to Improve Functioning in PAD

Inclusion Criteria

Exclusion Criteria

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