VEGF Gene Transfer for Critical Limb Ischemia

This study has been completed.
Sponsor:
Information provided by:
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00304837
First received: March 16, 2006
Last updated: October 18, 2010
Last verified: April 2008
  Purpose

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 high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.)

VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries.

The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study.

This study has been approved by the Food and Drug Administration (FDA).


Condition Intervention Phase
Critical Limb Ischemia
Ischemia
Leg Ulcer
Genetic: pVGI.1 (VEGF-2)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Losordo, Douglas, M.D.:

Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304837

Locations
United States, Alabama
Cardiology PC
Birmingham, Alabama, United States, 35211
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Minnesota
The Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Losordo, Douglas, M.D.
Investigators
Study Director: Douglas W. Losordo, MD Northwestern University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00304837     History of Changes
Other Study ID Numbers: BB-IND 11948
Study First Received: March 16, 2006
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Losordo, Douglas, M.D.:
Nonhealing leg ulcers
Ischemic rest pain

Additional relevant MeSH terms:
Ischemia
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014