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CompletedNCT00933998Updated Jan 29, 2014

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

An interventional study of Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate) in Diabetic Peripheral Neuropathy, sponsored by Carolina Musculoskeletal Institute. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-01-29.

Sponsored by Carolina Musculoskeletal Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • DPN
03

In context

Lead sponsor

This is the only study on the registry with Carolina Musculoskeletal Institute as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • History of back problems (Surgery or ECSI) or other large fiber neuropathies
  • History of chemotherapy
  • History of chemical exposure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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)

Interventions

  • OtherMetanx® (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.

    Also known as: Metanx

06

What researchers measure

Primary outcomes

  1. Epidermal Nerve Density Count

    Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy

    Time frame: 2 years

07

Study locations

1 site
  • Carolina Musculoskeletal Institute
    Aiken, South Carolina 29841, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00933998
Lead sponsor
Carolina Musculoskeletal Institute
Collaborators
Pamlab, L.L.C., Baylor University
Responsible party
Mackie J. Walker, Jr., DPM (Medical Director, Podiatry Division, Carolina Musculoskeletal Institute) — Principal investigator
First posted
Jul 8, 2009
Start date
Jun 2006
Primary completion
Oct 2008
Last update
Jan 29, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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