Peripheral Artery Disease Study
An Emory University research study to help people suffering from pain in their legs
Research conducted in Atlanta, GA
Compensation Provided
Peripheral
Artery Disease
On Stable Therapy
21 to 80 Years Old
Fast Facts
About this research study:
Peripheral arterial disease (PAD) is a common condition in older adults involving poor arterial circulation in the legs leading to leg pain and debility.
The body's own circulating blood vessel stem cells may help to improve circulation. Researchers at Emory University are conducting a study to determine if treatment with a drug called granulocyte macrophage colony stimulating factor (GM-CSF) might improve signs and symptoms of peripheral arterial disease by increasing levels of your body’s own stem cells.
Additional Information
Why is this study being done?
The GPAD-3 study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with peripheral arterial disease (PAD) and claudication (leg pain). GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells.
Is this study for me?
INCLUSION CRITERIA:
  • Males or females 21 and 80 years of age.
  • Angiographically documented PAD.
  • On stable statin therapy for previous 3 months.
  • Diabetics with a dilated eye exam excluding proliferative retinopathy in the previous 12 months.
EXCLUSION CRITERIA:
  • Recent or current active infections (treated with antibiotics);
  • Planned participation in a structured exercise treatment protocol in the future or within period of study;
  • Severe heart failure (Class III or IV), heart muscle disease or atrial fibrillation;
  • Use of a walking aid other than a cane;
  • Walking impairment for reasons other than PAD eg. Parkinson’s disease;
  • Uncontrolled diabetes mellitus (defined as HbA1c > 10.0);
  • Chronic renal disease (creatinine of >2.5 mg/dl) or hepatic disease (> 3 X elevations in AST and ALT);
  • Alcohol or drug abuse, or any other disease process that, in the opinion of the PI, will interfere with the ability of the patient to participate in the study.
What will happen if I participate in the study?
Participants in the study will be randomly selected to receive GM-CSF or a placebo. Participants will undergo baseline testing and will be trained to perform subcutaneous injections and instructed to walk until they develop claudication or symptomatic limitation at least three times a day.

The primary outcome is change in walking performance in the active treatment group after 6 months compared to the placebo group. The secondary outcome includes change in peak walking time at 6 months, changes in circulating progenitor cell levels, ankle brachial index (ABI), walking impairment questionnaire (WIQ) scores, and 36-item Short-Form Health Survey (SF-36) scores. Long-term follow up, by way of a telephone call, will occur with each participant one, two and three years after they enrolled in the study to administer questionnaires and collect adverse event data.
Will I be paid for being in this research study?
Compensation will be provided for those who qualify for the study.
Will it cost me anything to participate in this study?
There is no charge for participation in this study.