Trial record 7 of 7 for:    "small fiber neuropathy" OR "small nerve fiber neuropathy"

Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by St. Luke's Hospital and Health Network, Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Goldfarb Foundation
Pamlab, L.L.C.
Information provided by (Responsible Party):
Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier:
NCT01503892
First received: December 29, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Diabetes
Peripheral Neuropathy
Dietary Supplement: Metanx
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital and Health Network, Pennsylvania:

Primary Outcome Measures:
  • Increased intraepidermal nerve fiber density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Subjective improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Improvement in the subjective score versus the placebo group.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503892

Contacts
Contact: Edwin S. Hart III, DPM 610-868-4300 ehart@footmed.com

Locations
United States, Pennsylvania
St. Luke's Hospital and Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Edwin S. Hart III, DPM    610-868-4300    ehart@footmed.com   
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Goldfarb Foundation
Pamlab, L.L.C.
Investigators
Principal Investigator: Edwin S. Hart III, DPM St. Luke's Hospital and Health Network
  More Information

Additional Information:
PamLab  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Edwin S. Hart III, Principal Investigator, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT01503892     History of Changes
Other Study ID Numbers: StLukeHHN
Study First Received: December 29, 2011
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital and Health Network, Pennsylvania:
Small Fiber Neuropathy
Metanx Effect on Small Fiber Neuropathy
Metanx Effect on Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014