- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933998
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
January 28, 2014 updated by: Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes.
Metanx is a medical food available with a prescription from a physician.
It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively.
Subjects will be assigned to receive Metanx for 12 months.
Baseline quantitative sensory testing will be done before the patient receives Metanx.
Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Aiken, South Carolina, United States, 29841
- Carolina Musculoskeletal Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive diabetic patients entering the office (private practice)
- Subjective symptoms of numbness, burning, paresthesia, etc.
- Failed Monofilament of at least two points on each foot
- Abnormal PSSD study
Willing to participate in protocols or study
- Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily
- Keep scheduled appointments for follow up studies
- Report any other medical interventions, studies, or medication changes
- Report any problems of medical or psycho-social matters to investigators
- HgbA1c NOT monitored or specific value required for participation
Exclusion Criteria:
- History of back problems (Surgery or ECSI) or other large fiber neuropathies
- History of chemotherapy
- History of chemical exposure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metanx
Metanx bid for 2 weeks then daily.
Compare to non treated patient population
|
One pill twice a day for 2 weeks.
Then one pill a day until 12 month study is up.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidermal Nerve Density Count
Time Frame: 2 years
|
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (Estimate)
July 8, 2009
Study Record Updates
Last Update Posted (Estimate)
January 29, 2014
Last Update Submitted That Met QC Criteria
January 28, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMI-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Peripheral Neuropathy
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Pamlab, L.L.C.HealthCore, Inc.CompletedDiabetic Peripheral Neuropathy (DPN)United States
-
Riphah International UniversityRecruitingDiabetic Peripheral Neuropathy (DPN)Pakistan
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Tanta UniversityCompletedDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Painful Diabetic Neuropathy | Autonomic Neuropathy | Diabetic Polyneuropathy | Small Fiber NeuropathyEgypt
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October 6 UniversityCompletedDiabetic Neuropathy PeripheralEgypt
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Fengmei LianPeking Union Medical College Hospital; Huashan Hospital; Chengdu University of... and other collaboratorsUnknownDiabetic Peripheral Neuropathy Type 2China
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Wuhan Central HospitalWuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China; Wuhan...RecruitingDiabetic Peripheral Neuropathy Type 2China
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