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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Key information

Conditions

Diabetic Peripheral Neuropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Musculoskeletal Institute

Aiken, South Carolina, 29841, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)

Other

One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.

Other names: Metanx

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Carolina Musculoskeletal Institute

Other

Collaborators

Baylor University
Pamlab, L.L.C.

Registry information

Important dates

Study start: 2006
Primary completion: 2008
First posted: Jul 8, 2009
Registry last updated: Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed