Diabetic NeuropathyPhase 1/2NCT00056290
VEGF Gene Transfer for Diabetic Neuropathy
A Phase 1/2 study testing VEGF in people with Diabetic Neuropathy, run by Losordo, Douglas, M.D. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- VEGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2002to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC
Boston, Massachusetts, 02135
Columbia University Neuropathy Research Center, Neurological Institute
New York, New York, 10032
About this study
Official title: p.VGI.1 (VEGF2) 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- VEGF
- Keywords
- Diabetes Mellitus, Neuropathy, Peripheral Artery Disease
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGFBiological
3 sets of injections, at 2 week intervals
VEGFBiological
3 sets of injections, at 2 week intervals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | VEGF Receives: Biological: VEGF |
| 2 | Placebo comparator | Placebo Receives: Biological: VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2003 (estimated)
- Study startDec 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Losordo, Douglas, M.D.
- Investigators
- Allan H Ropper, M.D., Principal investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056290
- Sponsor's protocol ID
- BB-IND 11572
- Other IDs
- NIH #0104-467
- Status last verified
- Nov 2010
- First submitted
- 10 Mar 2003
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00056290
- Acronym / sponsor ID
- BB-IND 11572
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetes Mellitus, Neuropathy, Peripheral Artery Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Losordo, Douglas, M.D.
- Study start
- Dec 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: VEGFVEGF |
| 2 | Placebo comparator | Biological: VEGFPlacebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEGF3 sets of injections, at 2 week intervals | Biological | 1 |
| VEGF3 sets of injections, at 2 week intervals | Biological | 2 |
Primary outcome
Safety
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Caritas St. Elizabeth's Medical Center of BostonLink provided by the sponsor.
Related trials for Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan H Ropper, M.D. principal investigator
Steward St. Elizabeth's Medical Center of Boston, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VEGF in people with Diabetic Neuropathy, run by Losordo, Douglas, M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.