VEGF Gene Transfer for Diabetic Neuropathy

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VEGF

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Diabetes Mellitus, Neuropathy, Peripheral Artery Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC
Columbia University Neuropathy Research Center, Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

VEGF

Placebo

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Full Information

NCT ID

NCT00056290

First Posted

March 10, 2003

Last Updated

November 10, 2010

Sponsor

Losordo, Douglas, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT00056290

Brief Title

VEGF Gene Transfer for Diabetic Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Losordo, Douglas, M.D.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy

Keywords

Diabetes Mellitus, Neuropathy, Peripheral Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm Description

VEGF

Arm Title

2

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

VEGF

Intervention Description

3 sets of injections, at 2 week intervals

Intervention Type

Biological

Intervention Name(s)

VEGF

Intervention Description

3 sets of injections, at 2 week intervals

Primary Outcome Measure Information:

Title

Safety

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan H Ropper, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Columbia University Neuropathy Research Center, Neurological Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.semc.org

Description

Caritas St. Elizabeth's Medical Center of Boston

Diabetic Neuropathy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial