VEGF Gene Transfer for Diabetic Neuropathy - Full Text View

Sponsor:	Losordo, Douglas, M.D.
Information provided by:	Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:	NCT00056290

Purpose

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 I Phase II

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies Help Me Understand Genetics

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

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

Primary Outcome Measures:

Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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 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

Eligibility

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

Contacts and Locations

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

More Information

No publications provided

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
Study First Received:	March 10, 2003
Last Updated:	November 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Losordo, Douglas, M.D.:

Diabetes Mellitus
Neuropathy
Peripheral Artery Disease

Additional relevant MeSH terms:

Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases

Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 12, 2012