VEGF Gene Transfer for Diabetic Neuropathy

NCT00056290 | Completed Phase 1 DMC

• 2 other identifiers: BB-IND 11572NIH #0104-467
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Neuropathy

Keywords

Diabetes Mellitus; Neuropathy; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Safety

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

VEGF

Biological: VEGF

2

PLACEBO COMPARATOR

Placebo

Biological: VEGF

Interventions

VEGF BIOLOGICAL

3 sets of injections, at 2 week intervals

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Losordo, Douglas, M.D.: lead

Study Sites (2)

Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC

Boston, Massachusetts, 02135, United States

Location

Columbia University Neuropathy Research Center, Neurological Institute

New York, New York, 10032, United States

Location

Related Links

• Caritas St. Elizabeth's Medical Center of Boston

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Peripheral Arterial Disease

Interventions

Vascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Endothelial Growth Factors; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Allan H Ropper, M.D.

  Steward St. Elizabeth's Medical Center of Boston, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 10, 2003
• First Posted: March 11, 2003
• Study Start: December 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: November 11, 2010

Record last verified: 2010-11

Locations

US (2)