Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD)

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill exercise will significantly improve functional performance in patients with PAD more than GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel therapeutic options for patients with PAD, the current proposal is expected to identify mechanisms by which functional impairment is improved in patients with PAD.

Key facts

Study ID

NCT01408901

Run by

Northwestern University

People needed

210

Starts

2011-09-01

Expected to finish

2017-08-15

Last updated by the study team

2020-01-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with an ankle brachial index (ABI) ≤ 0.90 will be eligible for participation.
• Participants with an ABI > 0.90 but ≤ 1.00 who experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible.
• Participants with an ABI > 0.90 who have medical record evidence of prior lower extremity revascularization and experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible for inclusion.
• Participants with an ABI > 0.90 who have medical record evidence of a non-invasive vascular laboratory test result consistent with PAD. Note that a screen-positive test from Lifeline Screening is not sufficient for inclusion in the study.

You may not qualify if…

• The following exclusion criteria will be initially assessed by telephone:
• Below or above-knee amputation.
• Wheelchair confinement.
• Use of a walking aid other than a cane (i.e. people using walkers).
• Non-English speaking.
• Significant hearing impairment.
• Significant visual impairment.
• Diagnosis of Parkinson's disease.
• Inability to return to the medical center at the required visit frequency (three times per week).
• > Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion).
• Any increase in angina pectoris symptoms during the previous 6 months or angina at rest.
• Foot ulcer. (Participants with a foot ulcer will be excluded by telephone and/or during a baseline study visit).
• Lower extremity revascularization in the last three months or major orthopedic surgery during the previous three months.
• Myocardial infarction, stroke, or coronary artery bypass grafting during the previous 3 months.
• Major medical illnesses including end stage renal disease requiring dialysis and chronic lung disease requiring oxygen, since these individuals may not be able to adhere to study requirements. Participants who only use oxygen at night may still qualify.
• Potential participants who have received G-CSF, GM-CSF, or erythropoietin within the past year will be excluded because these interventions may influence study outcomes independently of the interventions.
• Pre-menopausal women will be excluded because cyclic estrogen changes can influence progenitor cell levels.
• Potential participants with diabetes and documented proliferative retinopathy will be excluded because GM-CSF may exacerbate this condition.
• Potential participants with a history of myeloid malignancy will be excluded because GM-CSF may exacerbate these conditions.
• Potential participants who have been treated for late stage cancer during the past three years, since GM-CSF may theoretically activate quiescent cancer cells.
• Planned lower extremity revascularization within the next 6 months.
• Current participation in another clinical trial. If a participant recently completed a clinical trial, at least three months must have passed before they can be considered for the PROPEL Trial. However, for a clinical trial of stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit of the stem cell or gene therapy clinical trial, so long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention.
• Walking for exercise at a level comparable to that targeted in our intervention.
• Current participation in or completion of a cardiac rehabilitation program within the last six months.
• The following exclusion criteria will be assessed at the time of the study visit or later:

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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