Status:
COMPLETED
VEGF Gene Transfer for Critical Limb Ischemia
Lead Sponsor:
Losordo, Douglas, M.D.
Conditions:
Critical Limb Ischemia
Ischemia
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to hig...
Eligibility Criteria
Inclusion
- Be at least 21 years old
- Have critical limb ischemia
- Have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram
- Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow
- Agree to participate in follow-up.
Exclusion
- Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years
- Be pregnant or lactating
- Have a history of alcohol or drug abuse within 3 months of screening
- Have advanced (Rutherford Category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene
- Have osteomyelitis
- Have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar sympathectomy within the 2 months preceding screening
- Be a suitable candidate for surgical or endovascular revascularization in the limb in which treatment is proposed
- Subjects in whom arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00304837
End Date
April 1 2008
Last Update
October 19 2010
Active Locations (3)
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1
Cardiology PC
Birmingham, Alabama, United States, 35211
2
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
3
The Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407