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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Carolina Musculoskeletal Institute:

Primary Outcome Measures:
  • 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


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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 7, 2009
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Carolina Musculoskeletal Institute:
DPN

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

ClinicalTrials.gov processed this record on November 20, 2014