VEGF Gene Transfer for Diabetic Neuropathy - Tabular View

Tracking Information

First Received Date ^ICMJE

March 10, 2003

Last Updated Date

July 30, 2008

Start Date ^ICMJE

December 2002

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00056290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

VEGF Gene Transfer for Diabetic Neuropathy

Official Title ^ICMJE

p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Neuropathy

Intervention ^ICMJE

Biological: VEGF

Study Arms / Comparison Groups

Active Comparator: VEGF
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00056290

Responsible Party

Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine, Northwestern University, Northwestern Memorial Hospital

Study ID Numbers ^ICMJE

BB-IND 11572, NIH #0104-467

Study Sponsor ^ICMJE

Losordo, Douglas, M.D.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Allan H Ropper, M.D.

Caritas St. Elizabeth's Medical Center of Boston

Information Provided By

Losordo, Douglas, M.D.

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP