|
VEGF for Diabetic Neuropathy Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about VEGF for Diabetic Neuropathy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. VEGF for Diabetic Neuropathy Clinical research trials and VEGF for Diabetic Neuropathy health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as VEGF for Diabetic Neuropathy. VEGF for Diabetic Neuropathy Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a VEGF for Diabetic Neuropathy clinical trial. Human subjects frequently get the finest healthcare available for their VEGF for Diabetic Neuropathy condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > VEGF for Diabetic Neuropathy  VEGF for Diabetic Neuropathy
VEGF for Diabetic Neuropathy
For Condition: Diabetic Neuropathy
Status: Recruiting
Sponsor(s): Losordo, Douglas, M.D. , Caritas St. Elizabeth's Medical Center of Boston,Allan H. Ropper, M.D.,David Weinberg, M.D.,Ann M. Pieczek, R.N, B.S.N.,Robert Schainfeld, D.O.,George L. Tully III, M.D.
Synopsis: The purpose of this clinical investigation is to investigate the safety and bioactivity of intramuscular gene transfer (using phVEGF165) in one of your legs. phVEGF165 is DNA, or genetic material. Once in the muscle of the leg, the DNA directs the cells of the artery wall to make a protein called vascular endothelial growth factor. This protein has been shown to cause new blood vessels to grow under a variety of conditions. We do not know if this will occur in your case. It is another purpose of this trial to make this determination, and to determine if sensory function in your legs improves following gene transfer. You may have decreased ability to feel things in your legs (diabetic neuropathy) due to diabetes. If you have been diagnosed with diabetic neuropathy associated with peripheral artery disease and it has been determined that you are not a candidate for conventional revascularization techniques such as angioplasty or lower extremity bypass surgery, you may be a candidate for enrollment into this research protocol. Once your screening and baseline assessments have been completed and your candidacy for the research study has been determined, you will be randomized to receive phVEGF165 or placebo (a salt water solution); there is a 1/4 chance you will receive placebo and a 3/4 chance you will receive phVEGF165. If you have been diagnosed with diabetic neuropathy in the absence of significant blockages in your leg arteries, you also may be a candidate for this research protocol. Once your screening and baseline assessments have been completed and your candidacy for the research study has been determined, you will be randomized into the second dosing cohort to receive phVEGF165 or placebo (a salt water solution); there is a 1/4 chance you will receive placebo and a 3/4 chance you will receive phVEGF165. Neither you nor your doctor will know if you receive the gene or placebo, your doctor, however, can obtain that information in the case of a medical emergency. You will be enrolled in the study only once and the gene transfer/placebo administration will be limited to one lower extremity.
Details:
Eligibility:
Study Type: Interventional,Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry 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 clinical evidence of a predominantly sensory neuropathy (as determined by a Neurologist and by EMG). - Have an ABI <0.90 in the affected leg; or, have previous evidence of peripheral arterial disease by plethysmography, angiography, or magnetic resonance angiography. - Women of child-bearing potential must agree to use all means available not to become pregnant during the course of the study. Nonsterile men participating in the study must also agree to use all means available to prevent pregnancy in their partners. - Have the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. - Agree to participate in follow-up. Exclusion criteria Patients are to be excluded from the trial if any of the following conditions are met: - Have any concomitant disease that results in a life expectancy of less than 1 year or that is sufficiently severe to compromise clinical follow-up examinations. - Have a history of alcohol or drug abuse within 3 months of screening. - Have any evidence (clinical, laboratory, or imaging) or history of neoplasm (other than non-melanoma skin carcinoma). - Have a mammogram which has at any time during the previous 5 years been interpreted as “suspicious.” - Have evidence of moderate to severe proliferative retinopathy on fundoscopic examination by an ophthalmologist. - Have any clinically significant abnormality in liver function test (defined as a value more than 2 times the upper limit of the normal range for that value); or, have any other laboratory value of clinical significance, in the opinion of the investigator. - Have undergone successful lower extremity surgical revascularization, percutaneous transluminal angioplasty, or lumbar sympathectomy within the 6 months preceding screening. - Be a suitable candidate for surgical or angioplastic revascularization in the limb in which treatment is proposed. - Is currently taking and/or unable to be withdrawn from any of the following therapies: prostaglandins, dextran, pentoxyfylline, L-carnitine, hyperbaric oxygen. (Patients are permitted to remain on risk factor modification therapy for their vascular disease provided they have been on a stable dose of these medications for at least 6 weeks prior to enrollment in the study and remain on these medications throughout the study period.) - Be pregnant or lactating. - Have > 3+ edema of the limb in which treatment is proposed. - Have an amputated great toe (or great toe compromised by an ulcer) in the limb to be injected that would prevent neurological and quantitative sensory testing. - Be unsuitable for participation in the study, in the opinion of the Investigator.
Total Enrollment: 192
Location and Contact Information:
Overall Study Official:
AllanRopper, Principal Investigator, Caritas St. Elizabeth's Medical Center of Boston
Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC *Recruiting*
Boston, Massachusetts, 02135
United States
Recruiting Daniela Grasso 617-779-6394
Additional Information:
Study ID Numbers: IRB #04010000; NIH #0104-467
Study Start Date: December 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056290
Other Diabetic Neuropathy Studies:
1. VEGF for Diabetic Neuropathy
Related Studies:
Other Diabetic Neuropathy Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
VEGF for Diabetic Neuropathy
|
|
|
|
|
|
|
|
