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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00797056
First received: November 20, 2008
Last updated: March 30, 2015
Last verified: March 2015

November 20, 2008
March 30, 2015
April 2008
April 2012   (final data collection date for primary outcome measure)
Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Major limb amputation rate at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00797056 on ClinicalTrials.gov Archive Site
  • Toe pressure index [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]

    -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.
  • Toe pressure [ Time Frame: Pre-study and day 1, 10, 30, 90 and 365 ] [ Designated as safety issue: No ]
  • Ankle-brachial index [ Time Frame: Pre-study and at day 1, 10, 30, 90, and 365 ] [ Designated as safety issue: No ]
  • Ulcer healing and improvement in rest pain [ Time Frame: Pre-study and at day 1, 10, 30, 90 and 365 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease
Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Vascular Diseases
  • 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
  • Experimental: G-CSF
    Interventions:
    • Drug: G-CSF
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Aspirin
    • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797056
07-0043 / 201106083
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Patrick Geraghty, M.D. Washington University School of Medicine
Washington University School of Medicine
March 2015

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