Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease (GPAD-2)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT01041417
First received: December 29, 2009
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: May 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Drug: Granulocyte-Macrophage Stimulating Factor (GM-CSF)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 2010 and July 2012, 322 individuals with peripheral artery disease were assessed for eligibility. 159 subjects were enrolled into the study from Emory Healthcare, Veterans Affairs hospitals in Atlanta, and Medical College of Georgia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GM-CSF

Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks

500 microgram dose of GM-CSF

Placebo Saline injection - three times for four weeks

Participant Flow:   Overall Study
    GM-CSF     Placebo  
STARTED     80     79  
COMPLETED     73     76  
NOT COMPLETED     7     3  
Adverse Event                 5                 2  
Lost to Follow-up                 1                 1  
Death                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GM-CSF

Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks

500 microgram dose of GM-CSF

Placebo Saline injection - three times for four weeks
Total Total of all reporting groups

Baseline Measures
    GM-CSF     Placebo     Total  
Number of Participants  
[units: participants]
  80     79     159  
Age  
[units: years]
Mean (Standard Deviation)
  64.3  (7.9)     63.6  (7.9)     63.9  (7.9)  
Gender  
[units: participants]
     
Female     10     10     20  
Male     70     69     139  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     45     34     79  
White     33     45     78  
More than one race     0     0     0  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     80     79     159  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

2.  Secondary:   Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

3.  Secondary:   Change in Claudication Onset Time (COT) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

4.  Secondary:   Change in Claudication Onset Time (COT) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

5.  Secondary:   Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

6.  Secondary:   Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

7.  Secondary:   Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

8.  Secondary:   Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

9.  Secondary:   Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

10.  Secondary:   Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

11.  Secondary:   Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

12.  Secondary:   Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

13.  Secondary:   Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

14.  Secondary:   Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]

15.  Secondary:   Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months   [ Time Frame: Baseline, 3 months ]

16.  Secondary:   Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Arshed Quyyumi
Organization: Emory University School of Medicine
phone: 4047273655
e-mail: aquyyum@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier: NCT01041417     History of Changes
Other Study ID Numbers: IRB00030362, 1RC2HL101515-01
Study First Received: December 29, 2009
Results First Received: May 15, 2014
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration