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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933998
First Posted: July 8, 2009
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pamlab, L.L.C.
Baylor University
Information provided by (Responsible Party):
Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute
  Purpose
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 Intervention
Diabetic Peripheral Neuropathy Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)

Study Type: Interventional
Study Design: 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®

Resource links provided by NLM:


Further study details as provided by Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: June 2006
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: July 7, 2009
First Posted: July 8, 2009
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