VEGF Gene Transfer for Diabetic Neuropathy | NCT00056290

Studies
VEGF Gene Transfer for Diabetic Neuropathy

NCT00056290

Sponsor

Losordo, Douglas, M.D.

Status

Completed

Last Update Posted

Nov 11, 2010Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Diabetic Neuropathy

Interventions

VEGF
VEGF

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIH #0104-467

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Dec 2002

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Mar 10, 2003

First Submission Date that Met QC Criteria

Mar 10, 2003

First Posted Date

Mar 11, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2010

Last Update Posted Date

Nov 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	VEGF	Biological: VEGF
2	Placebo Comparator	Placebo	Biological: VEGF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VEGF	Biological	3 sets of injections, at 2 week intervals	1
VEGF

Measure	Description	Time Frame
Safety		6 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan H Ropper, M.D.	Steward St. Elizabeth's Medical Center of Boston, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC		Boston	Massachusetts	02135	United States

Label	URL
Caritas St. Elizabeth's Medical Center of Boston	View source

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies
D003920	Diabetes Mellitus
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D042461	Vascular Endothelial Growth Factor A

Ancestor Terms

ID	Term
D042442	Vascular Endothelial Growth Factors
D042501	Angiogenic Proteins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided