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NCT03304821 · ClinicalTrials.gov registry record · Phase 2

Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease

A Phase 2 study of Peripheral Artery Disease (PAD), sponsored by Emory University.

Recruiting
Registry status
Phase 2
Development phase
176
Enrollment target
1
Study location

NCT03304821 is a Phase 2 study of Peripheral Artery Disease (PAD) that is actively recruiting participants, run by Emory University. The registered enrollment target is 176 participants, below the 254-participant average among 5 other Peripheral Artery Disease (PAD) trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03304821, a Phase 2 study of Peripheral Artery Disease (PAD), is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 2
Development phase
176 participants
Enrollment target
1
Study location

Study Summary

Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.

Conditions Studied

Peripheral Artery Disease (PAD)

Interventions

  • DRUG Placebo
  • DRUG GM-CSF

Study Locations (1)

Georgia

  • Emory University Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2017-12-19
Est. Completion 2025-12
Phase Phase 2

Sponsor

Emory University

1,208 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03304821

The ClinicalTrials.gov registry entry for NCT03304821 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 5 other Peripheral Artery Disease (PAD) trials with a reported enrollment target (31% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Artery Disease (PAD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03304821 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT03304821 about?

NCT03304821 is a clinical study titled "Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease". Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-ri...

What is the current status of trial NCT03304821?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2017-12-19. Estimated completion is 2025-12.

What conditions does trial NCT03304821 study?

This clinical trial studies the following conditions: Peripheral Artery Disease (PAD).

What interventions are being tested in trial NCT03304821?

The interventions under investigation include: Placebo (DRUG), GM-CSF (DRUG).

Who is sponsoring clinical trial NCT03304821?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03304821 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.