Overview

Use Art-assist and Neupogen to Treat Chronic Limb Ischemia

Status:
Withdrawn

Trial end date:
2015-07-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to measure the concentration of cells and proteins in the patient's blood during administration of Nuopogen (Filgrastim), a medication that is FDA approved for stem cell mobilization, in combination with a programmed pneumatic compression device (PPCD) (Art-Assist Device). The Art-Assist Device is an FDA approved device that promotes blood flow in the patient's legs. A patient will be prescribed this device and this drug to help improve the poor circulation in his/her leg. The use of Nuopogen along with the Art-Assist Device has not been approved by the FDA and is considered experimental. This study is not designed to find out how well the Art-Assist Device works, nor how well the drug works in mobilizing stem cells. Instead, it is a study of how well cells lining blood vessels in calf respond to increases in shear stress, and how well the increase in the population of certain cells in the blood stream effect how the new blood vessels will form. It is important for clinical reasons, and for the purposes of this study, that the patient uses the Art-Assist Device as prescribed on a daily basis as discussed with the patient's doctor

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Chicago

Treatments:

Lenograstim

Criteria

Inclusion Criteria:

1. Male or female between the ages of 40 and 85.

2. Chronic limb ischemia Fontaine Class III (ischemic forefoot rest pain) and Class IV
(non-healing ischemic ulcers, gangrene) with confirmatory non-invasive vascular
testing.

Exclusion Criteria:

1. Acute limb ischemia requiring emergency treatment.

2. Non-salvageable foot (e.g. extensive gangrene, advanced infection, rigor mortis,
knee/hip flexion contracture, post-stroke paralysis, and hemiparesis).

3. Untreated hypercoagulability disorder, sickle cell anemia, myeloproliferative
disorder.

4. Dialysis, and sustained elevated Creatinine > 4 mg/dl.

5. Severe dementia; bed-ridden; non-compliance; unlikely to follow-up; unreliable.

6. Intolerance of PPCD compression

7. Morbid obesity (Body Mass Index > 34)

8. Severe venous insufficiency causing venous stasis ulceration and dermatitis.

9. Uncorrected significant aorto-iliac, common femoral, and profunda femoral arterial
disease

10. Ulceration precluding PPCD placement.

11. Active cancer.

12. Allergy to Nuopogen.

13. Uncorrected symptomatic coronary artery disease

14. History of lymphoma or leukemia