VEGF Gene Transfer for Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathy Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Nervous System Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VEGF

Biological

3 sets of injections, at 2 week intervals

Primary outcomes

Safety

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Losordo, Douglas, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2008
First posted: Mar 11, 2003
Registry last updated: Nov 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed