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Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

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ClinicalTrials.gov Identifier: NCT00933998
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : January 29, 2014
Sponsor:
Collaborators:
Pamlab, L.L.C.
Baylor University
Information provided by (Responsible Party):
Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
Study Start Date : June 2006
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Mecobalamin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metanx
Metanx bid for 2 weeks then daily. Compare to non treated patient population
Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.
Other Name: Metanx



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933998


Locations
United States, South Carolina
Carolina Musculoskeletal Institute
Aiken, South Carolina, United States, 29841
Sponsors and Collaborators
Carolina Musculoskeletal Institute
Pamlab, L.L.C.
Baylor University

Responsible Party: Mackie J. Walker, Jr., DPM, Medical Director, Podiatry Division, Carolina Musculoskeletal Institute
ClinicalTrials.gov Identifier: NCT00933998     History of Changes
Other Study ID Numbers: CMI-01
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute:
DPN

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin B 12
Pyridoxal
Pyridoxal Phosphate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs