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

This study has been completed.
Sponsor:
Collaborators:
Pamlab, L.L.C.
Baylor University
Information provided by (Responsible Party):
Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute
ClinicalTrials.gov Identifier:
NCT00933998
First received: July 7, 2009
Last updated: January 28, 2014
Last verified: January 2014

July 7, 2009
January 28, 2014
June 2006
October 2008   (final data collection date for primary outcome measure)
Epidermal Nerve Density Count [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
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Complete list of historical versions of study NCT00933998 on ClinicalTrials.gov Archive Site
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Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
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
Experimental: Metanx
Metanx bid for 2 weeks then daily. Compare to non treated patient population
Intervention: Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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October 2008   (final data collection date for primary outcome measure)

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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933998
CMI-01
No
Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute
Carolina Musculoskeletal Institute
  • Pamlab, L.L.C.
  • Baylor University
Not Provided
Carolina Musculoskeletal Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP