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NCT01041417 · ClinicalTrials.gov registry record · Phase 2
Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT01041417: Completed Phase 2 study, sponsored by Emory University.
NCT01041417 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041417, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study Summary
Peripheral arterial disease 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. This study will test whether treatment with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy. As well this study will examine whether improvements in blood vessel function can be observed. Finally, we will measure blood vessel function and stem cell levels in order to determine whether they can help to predict whether patients wither peripheral arterial disease will suffer further cardiovascular complications.
Primary Outcome
Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.
Interventions
- DRUG Placebo
- DRUG Granulocyte-Macrophage Stimulating Factor (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2009-09 |
| Phase | Phase 2 |
What the finished NCT01041417 record still lists
NCT01041417 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01041417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041417 about?
NCT01041417 is a clinical study titled "Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease". Peripheral arterial disease 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. This study will test whether treatment with the drug granulocyte mac...
What is the current status of trial NCT01041417?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2009-09.
What interventions are being tested in trial NCT01041417?
The interventions under investigation include: Placebo (DRUG), Granulocyte-Macrophage Stimulating Factor (GM-CSF) (DRUG).
Who is sponsoring clinical trial NCT01041417?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041417's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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