Trial · NCT01041417

Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease

NCT01041417, Phase 2, Completed, Emory University; results first posted 2014-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease. Trials, record NCT01041417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041417

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease
NCT number: NCT01041417
Status: Completed
Phases: Phase 2
Enrollment: 159 participants, actual
Lead sponsor: Emory University
Conditions: Peripheral Arterial Disease
Interventions: Granulocyte-Macrophage Stimulating Factor (GM-CSF), Placebo
First posted: 2009-12-31
Last updated: 2014-12-23
Results first posted: 2014-12-23
Limitations and caveats: Study population were subjects with claudication who underwent angiography. Study design could not show therapeutic benefit of GM-CSF therapy with dose and duration changes. And study design encouraged all subjects to walk to claudication daily.

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months	Baseline, 3 months	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.
Secondary	Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months	Baseline, 6 months	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.
Secondary	Change in Claudication Onset Time (COT) From Baseline to 3 Months	Baseline, 3 months	Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.
Secondary	Change in Claudication Onset Time (COT) From Baseline to 6 Months	Baseline, 6 months	Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.
Secondary	Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.
Secondary	Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.
Secondary	Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.
Secondary	Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.
Secondary	Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.
Secondary	Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months	Baseline, 3 months	seconds	MEAN
SECONDARY	Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months	Baseline, 6 months	seconds	MEAN
SECONDARY	Change in Claudication Onset Time (COT) From Baseline to 3 Months	Baseline, 3 months	seconds	MEAN
SECONDARY	Change in Claudication Onset Time (COT) From Baseline to 6 Months	Baseline, 6 months	seconds	MEAN
SECONDARY	Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	units on a scale	MEAN
SECONDARY	Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	units on a scale	MEAN
SECONDARY	Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	units on a scale	MEAN
SECONDARY	Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	units on a scale	MEAN
SECONDARY	Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Baseline, 3 months	units on a scale	MEAN
SECONDARY	Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months	Baseline, 6 months	units on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months	GM-CSF	109	95% Confidence Interval 248	seconds
Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months	Placebo	56	95% Confidence Interval 182	seconds
Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months	GM-CSF	112	95% Confidence Interval 71 to 153	seconds
Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months	Placebo	77	95% Confidence Interval 36 to 117	seconds
Change in Claudication Onset Time (COT) From Baseline to 3 Months	GM-CSF	81	95% Confidence Interval 52 to 111	seconds
Change in Claudication Onset Time (COT) From Baseline to 3 Months	Placebo	61	95% Confidence Interval 32 to 91	seconds
Change in Claudication Onset Time (COT) From Baseline to 6 Months	GM-CSF	93	95% Confidence Interval 64 to 122	seconds
Change in Claudication Onset Time (COT) From Baseline to 6 Months	Placebo	61	95% Confidence Interval 33 to 89	seconds
Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	GM-CSF	12.5	95% Confidence Interval 27.6	units on a scale
Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months	Placebo	4.8	95% Confidence Interval 24.8	units on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GM-CSF	80
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	GM-CSF	73
Overall Study	COMPLETED	Placebo	76
Overall Study	NOT COMPLETED	GM-CSF	7
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headaches	Nervous system disorders	GM-CSF	18	80	18
other	Headaches	Nervous system disorders	Placebo	9	79	9
other	Difficulty breathing	Cardiac disorders	GM-CSF	5	80	5
other	Difficulty breathing	Cardiac disorders	Placebo	8	79	8
other	Chest pain	Cardiac disorders	GM-CSF	6	80	6
other	Chest pain	Cardiac disorders	Placebo	7	79	7
other	Joint/back/muscle pain	Musculoskeletal and connective tissue disorders	GM-CSF	18	80	18
other	Joint/back/muscle pain	Musculoskeletal and connective tissue disorders	Placebo	14	79	14
other	Gastrointestinal side effects	Gastrointestinal disorders	GM-CSF	21	80	21
other	Gastrointestinal side effects	Gastrointestinal disorders	Placebo	11	79	11

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GM-CSF
Total, all-cause mortality	Placebo
Total, other adverse events	GM-CSF	79	80
Total, other adverse events	Placebo	69	79
Total, serious adverse events	GM-CSF	9	80
Total, serious adverse events	Placebo	9	79

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24247554	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
RC2HL101515	Phase II study: Mobilization of progenitor cells in peripheral arterial disease	QUYYUMI, ARSHED A	EMORY UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2009 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
GM-CSF vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01041417

GET https://conductscience.org/api/trials/v1/NCT01041417/results?page=2

API reference For AI assistants