Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03304821
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2017-10-04
Brief Title:
Granulocyte-Macrophage Stimulating Factor GM-CSF in Peripheral Arterial Disease
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Granulocyte-Macrophage Stimulating Factor GM-CSF in Peripheral Arterial Disease The GPAD-3 Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPAD-3
Brief 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
Detailed Description:
Atherosclerotic peripheral artery disease PAD of the lower extremities afflicts up to 8 of the US population and lack of adequate sustainable therapies necessarily results in severe morbidity and increased mortality Both experimental and current clinical data indicate that GM-CSF has the capacity to mobilize a variety of progenitor cells PCs including endothelial PCs that appear to improve ischemia
This study builds on the findings of prior research which showed improvements in claudication symptoms after treatment with GM-CSF This study aims to answer whether repeat administration of GM-CSF at 3 months will further improve symptoms The researchers will investigate in a double-blind placebo-controlled randomized study whether 3 weeks of three-times-a-week injection of GM-CSF will improve measures of ischemia in patients with intermittent claudication
This study will recruit 176 participants with atherosclerotic PAD and claudication After screening for inclusion and exclusion criteria eligible subjects will be trained to perform subcutaneous injections and instructed to walk until they develop claudication or symptomatic limitation at least three times a day for 4 weeks At the end of the 4-week period subjects will undergo baseline testing and will be randomized to receive 500 μgday of GM-CSF thrice weekly for 3 weeks group A or a placebo group B After 3 months follow-up endpoint testing will be performed Subjects in group A will then receive the second administration of 500 μgday of subcutaneous GM-CSF thrice weekly for another 3 weeks and be followed for another 3 months for endpoint measurements while Group B subjects will receive a matching placebo 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
In response to the Coronavirus Disease 2019 COVID-19 crisis on April 3 2020 the Institutional Review Board IRB approved temporary modifications to this study to postpone study visits that do not involve active drugplacebo use
This study builds on the findings of prior research which showed improvements in claudication symptoms after treatment with GM-CSF This study aims to answer whether repeat administration of GM-CSF at 3 months will further improve symptoms The researchers will investigate in a double-blind placebo-controlled randomized study whether 3 weeks of three-times-a-week injection of GM-CSF will improve measures of ischemia in patients with intermittent claudication
This study will recruit 176 participants with atherosclerotic PAD and claudication After screening for inclusion and exclusion criteria eligible subjects will be trained to perform subcutaneous injections and instructed to walk until they develop claudication or symptomatic limitation at least three times a day for 4 weeks At the end of the 4-week period subjects will undergo baseline testing and will be randomized to receive 500 μgday of GM-CSF thrice weekly for 3 weeks group A or a placebo group B After 3 months follow-up endpoint testing will be performed Subjects in group A will then receive the second administration of 500 μgday of subcutaneous GM-CSF thrice weekly for another 3 weeks and be followed for another 3 months for endpoint measurements while Group B subjects will receive a matching placebo 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
In response to the Coronavirus Disease 2019 COVID-19 crisis on April 3 2020 the Institutional Review Board IRB approved temporary modifications to this study to postpone study visits that do not involve active drugplacebo use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61HL138657 | NIH | None | httpsreporternihgovquickSearch1R61HL138657 |