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VEGF Gene Transfer for Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00056290
Recruitment Status : Completed
First Posted : March 11, 2003
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Losordo, Douglas, M.D.

Brief Summary:
This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Biological: VEGF Phase 1 Phase 2

Expanded Access : Losordo, Douglas, M.D. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy
Study Start Date : December 2002
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
VEGF
Biological: VEGF
3 sets of injections, at 2 week intervals

Placebo Comparator: 2
Placebo
Biological: VEGF
3 sets of injections, at 2 week intervals




Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

To be eligible to enroll and remain in the study, patients must meet the following criteria:

  • Be at least 21 years old.
  • Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.
  • Have peripheral neuropathy related to diabetes.

Exclusion criteria

Patients are to be excluded from the trial if any of the following conditions are met:

  • Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
  • Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056290


Locations
United States, Massachusetts
Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC
Boston, Massachusetts, United States, 02135
United States, New York
Columbia University Neuropathy Research Center, Neurological Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Losordo, Douglas, M.D.
Investigators
Principal Investigator: Allan H Ropper, M.D. Steward St. Elizabeth's Medical Center of Boston, Inc.

Additional Information:
Responsible Party: Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine, Northwestern University, Northwestern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00056290     History of Changes
Other Study ID Numbers: BB-IND 11572
NIH #0104-467
First Posted: March 11, 2003    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by Losordo, Douglas, M.D.:
Diabetes Mellitus
Neuropathy
Peripheral Artery Disease

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases