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VEGF Gene Transfer for Diabetic Neuropathy

This study has been completed.
Information provided by:
Losordo, Douglas, M.D. Identifier:
First received: March 10, 2003
Last updated: November 10, 2010
Last verified: November 2010
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 Intervention Phase
Diabetic Neuropathy Biological: VEGF Phase 1 Phase 2

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
Study Design: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Safety [ Time Frame: 6 months ]

Estimated Enrollment: 60
Study Start Date: December 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Biological: VEGF
3 sets of injections, at 2 week intervals
Placebo Comparator: 2
Biological: VEGF
3 sets of injections, at 2 week intervals


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

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.
  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 identifier: NCT00056290

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.
Principal Investigator: Allan H Ropper, M.D. Steward St. Elizabeth's Medical Center of Boston, Inc.
  More Information

Additional Information:
Responsible Party: Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine, Northwestern University, Northwestern Memorial Hospital Identifier: NCT00056290     History of Changes
Other Study ID Numbers: BB-IND 11572
NIH #0104-467
Study First Received: March 10, 2003
Last Updated: November 10, 2010

Keywords provided by Losordo, Douglas, M.D.:
Diabetes Mellitus
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 processed this record on September 25, 2017