Critical Limb IschemiaPhase 1NCT00304837
VEGF Gene Transfer for Critical Limb Ischemia
A Phase 1 study testing pVGI.1 (VEGF-2) in people with Critical Limb Ischemia and Ischemia, run by Losordo, Douglas, M.D. at 3 sites in United States.
Trial summary
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- What is being tested?
- pVGI.1 (VEGF-2)
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Apr 2008
- Phase
- Phase 1
- 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
- Adult, Older adult
Who may be able to join
- Be at least 21 years old
- Have critical limb ischemia
- Have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram
- Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow
- Agree to participate in follow-up.
Who cannot join
- Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years
- Be pregnant or lactating
- Have a history of alcohol or drug abuse within 3 months of screening
- Have advanced (Rutherford Category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene
- Have osteomyelitis
- Have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar sympathectomy within the 2 months preceding screening
- Be a suitable candidate for surgical or endovascular revascularization in the limb in which treatment is proposed
- Subjects in whom arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cardiology PC
Birmingham, Alabama, 35211
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
The Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.)
VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries.
Read more
The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study.
This study has been approved by the Food and Drug Administration (FDA).
- Conditions
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- Being tested
- pVGI.1 (VEGF-2)
- Keywords
- Nonhealing leg ulcers, Ischemic rest pain
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Ischemia, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pVGI.1 (VEGF-2)Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Losordo, Douglas, M.D.
- Investigators
- Douglas W. Losordo, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304837
- Sponsor's protocol ID
- BB-IND 11948
- Status last verified
- Apr 2008
- First submitted
- 16 Mar 2006
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF Gene Transfer for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00304837
- Acronym / sponsor ID
- BB-IND 11948
- Conditions
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- Keywords
- Nonhealing leg ulcers, Ischemic rest pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Losordo, Douglas, M.D.
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Mar 2006 (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.
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.)
VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries.
The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study.
This study has been approved by the Food and Drug Administration (FDA).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 21 years old
- Have critical limb ischemia
- Have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram
- Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow
- Agree to participate in follow-up.
Key exclusion criteria (8 listed)
- Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years
- Be pregnant or lactating
- Have a history of alcohol or drug abuse within 3 months of screening
- Have advanced (Rutherford Category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene
- Have osteomyelitis
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 |
|---|---|---|
| pVGI.1 (VEGF-2) | Genetic | – |
Primary outcome
Not reported in the source record.
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 19 Oct 2010.
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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.
Douglas W. Losordo, MD study director
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pVGI.1 (VEGF-2) in people with Critical Limb Ischemia and Ischemia, run by Losordo, Douglas, M.D. at 3 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 5 inclusion and 8 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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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.
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 19 Oct 2010.