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

Completed · Not applicable

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID: NCT00933998
Run by: Carolina Musculoskeletal Institute
People needed: 20
Starts: 2006-06-01
Last updated by the study team: 2014-01-29

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Carolina Musculoskeletal Institute — Aiken, South Carolina, United States

Full record on ClinicalTrials.gov

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