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Trial record 4 of 29 for:    stem cell peripheral arterial disease | ( Map: United States )

Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD)

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ClinicalTrials.gov Identifier: NCT00797056
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Major limb amputation rate at one year [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00797056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Toe pressure index [ Time Frame: Up to 1 year ]
    Toe brachial index (TBI) and is a calculation based on the systolic blood pressures of the arm and the systolic blood pressures of the toes. The examination is performed with a photoplethysmograph (PPG) infrared light sensor and a very small blood pressure cuff placed around the toe. The arm and big toe systolic blood pressure measurements are recorded. Then the big toe systolic pressures are divided by the highest arm pressure to establish an TBI measurement for each leg. A TBI of .75 or greater is consider normal.
  • Ankle-brachial index [ Time Frame: Up to 1 year ]
    • The Ankle Brachial Index (ABI or ABPI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries (peripheral vascular disease or PVD). The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
    • A normal resting ankle-brachial index is 1 or 1.1.
    A resting ankle-brachial index of less than 1 is abnormal. If the ABI is:
    • Less than 0.95, significant narrowing of one or more blood vessels in the legs is indicated.
    • Less than 0.8, pain in the foot, leg, or buttock may occur during exercise (intermittent claudication).
    • Less than 0.4, symptoms may occur when at rest.
    • 0.25 or below, severe limb-threatening peripheral artery disease is probably present.
  • Ulcer healing as measured by surface area and depth [ Time Frame: Up to 1 year ]
    • Skin ulcerations should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeat measurements. A maximum of 3 ulcers on each lower extremity will be followed.
    • An average of the longest diameter for all ulcerations will be calculated and reported as the baseline average longest diameter. The baseline average will be used as reference by which to characterize the ulcerations.
  • Improvement in rest pain as measured by the Vascular Quality of Life Questionnaire [ Time Frame: Up to 1 year ]
    -25 questions including questions in activity, symptom, pain, emotional, and social domains. Each question has seven choices ranging from "All" to "None"
    • Each domain is scored 1-7=the total of domain item scores divided by the number of questions in the domain.
    • The total score is is also scored 1-7=the total of all the item scores divided by 25.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
  • Toe pressure [ Time Frame: Pre-study and day 1, 10, 30, 90 and 365 ]
  • Ankle-brachial index [ Time Frame: Pre-study and at day 1, 10, 30, 90, and 365 ]
  • Ulcer healing and improvement in rest pain [ Time Frame: Pre-study and at day 1, 10, 30, 90 and 365 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease
Official Title  ICMJE Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)
Brief Summary This study is designed to test the use of G-CSF in peripheral vascular disease. The investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result in a sustained improvement in blood flow in patients with severe peripheral arterial disease.
Detailed Description

One fourth of patients with peripheral artery disease (PAD) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (CLI). In patients with CLI, the risk of limb amputation at 1 year is 50%. In addition, patients with CLI often have rest pain, non-healing ulcers and severe limitations of ambulation. Revascularization procedures, including bypass surgery, percutaneous transluminal angioplasty and angioplasty with stenting, are currently the only treatment options. However, many patients are not eligible for a revascularization procedure due to small vessel disease or coexisting medical problems. Moreover, restenosis rates are high.

There is currently no effective non-invasive treatment for critical limb ischemia. We hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate angiogenesis in areas of ischemia and result in a sustained improvement in blood flow in patients with severe PAD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Diseases
Intervention  ICMJE
  • Drug: G-CSF
    G-CSF 5 mcg/kg/day SQ daily for 10 days
    Other Names:
    • Filgrastim
    • Neupogen
  • Drug: Placebo
    Saline SQ daily for 10 days
    Other Name: NaCl
  • Drug: Aspirin
    Aspirin 75 mg/day for 14 days
    Other Name: acetylsalicylate
  • Drug: Clopidogrel
    Clopidogrel 75mg/day daily for 14 days
    Other Name: Plavix
Study Arms  ICMJE
  • Experimental: G-CSF
    Interventions:
    • Drug: G-CSF
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Aspirin
    • Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
60
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
  • Patients must have a toe pressure ≤ 30 mm Hg.
  • Patients must be ≥18 years old.
  • Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
  • Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
  • After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.

Exclusion Criteria:

  • Patients with transmetatarsal or higher amputations in the affected limb are excluded.
  • Patients who are candidates for a revascularization procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797056
Other Study ID Numbers  ICMJE 07-0043 / 201106083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Geraghty, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP