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History of Changes for Study: NCT01503892
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
Latest version (submitted July 16, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 31, 2011 None (earliest Version on record)
2 July 16, 2012 Recruitment Status and Study Status
Comparison Format:

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Study NCT01503892
Submitted Date:  December 31, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: StLukeHHN
Brief Title: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
Official Title: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2011
Overall Status: Recruiting
Study Start: December 2011
Primary Completion: April 2013 [Anticipated]
Study Completion:
First Submitted: December 29, 2011
First Submitted that
Met QC Criteria:
December 31, 2011
First Posted: January 4, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 31, 2011
Last Update Posted: January 4, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Responsible Party: Principal Investigator
Investigator: Edwin S. Hart III
Official Title: Principal Investigator
Affiliation: St. Luke's Hospital and Health Network, Pennsylvania
Collaborators: Goldfarb Foundation
Pamlab, L.L.C.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetes
Peripheral Neuropathy
Keywords: Small Fiber Neuropathy
Metanx Effect on Small Fiber Neuropathy
Metanx Effect on Diabetic Peripheral Neuropathy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo
The control group will receive placebo pill twice daily for twelve months.
Drug: Placebo
Placebo- one tablet twice daily for twelve months.
Active Comparator: Metanx
Metanx group will receive one pill twice daily for twelve months.
Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Increased intraepidermal nerve fiber density
[ Time Frame: 1 year ]

If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density
Secondary Outcome Measures:
1. Subjective improvement
[ Time Frame: 1 year ]

Improvement in the subjective score versus the placebo group.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Type 2 Diabetics
  • Pre-diabetics
  • Symptoms of peripheral neuropathy

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)
Open or close this module Contacts/Locations
Central Contact Person: Edwin S. Hart III, DPM
Telephone: 610-868-4300
Email: ehart@footmed.com
Study Officials: Edwin S. Hart III, DPM
Principal Investigator
St. Luke's Hospital and Health Network
Locations: United States, Pennsylvania
St. Luke's Hospital and Health Network
[Recruiting]
Bethlehem, Pennsylvania, United States, 18015
Contact:Contact: Edwin S. Hart III, DPM 610-868-4300 ehart@footmed.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: William L. Goldfarb Educational Foundation for Research and Teaching of the Lower Extremity
Description: PamLab
Description: St. Luke's Hospital and Health Network
Available IPD/Information:

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