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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
Sponsored by
Carolina Musculoskeletal Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring DPN

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carolina Musculoskeletal Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metanx

Arm Description

Metanx bid for 2 weeks then daily. Compare to non treated patient population

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
January 28, 2014
Sponsor
Carolina Musculoskeletal Institute
Collaborators
Pamlab, L.L.C., Baylor University
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1. Study Identification

Unique Protocol Identification Number
NCT00933998
Brief Title
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
Official Title
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carolina Musculoskeletal Institute
Collaborators
Pamlab, L.L.C., Baylor University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
DPN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metanx
Arm Type
Experimental
Arm Description
Metanx bid for 2 weeks then daily. Compare to non treated patient population
Intervention Type
Other
Intervention Name(s)
Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
Other Intervention Name(s)
Metanx
Intervention Description
One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.
Primary Outcome Measure Information:
Title
Epidermal Nerve Density Count
Description
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Carolina Musculoskeletal Institute
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29841
Country
United States

12. IPD Sharing Statement

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

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