Status:
COMPLETED
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
Lead Sponsor:
Carolina Musculoskeletal Institute
Collaborating Sponsors:
Pamlab, L.L.C.
Baylor University
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
Phase:
NA
Brief 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 co...
Eligibility Criteria
Inclusion
- 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
- History of back problems (Surgery or ECSI) or other large fiber neuropathies
- History of chemotherapy
- History of chemical exposure
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00933998
Start Date
June 1 2006
Last Update
January 29 2014
Active Locations (1)
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1
Carolina Musculoskeletal Institute
Aiken, South Carolina, United States, 29841