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Controlled, Randomized, Double-Blinded, Prospective Study On the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression

This study is currently Recruiting

August 2011 By University of Texas Southwestern Medical Center

First Recieved on June 19, 2008

Last Updated on August 10, 2011

Sponsor: University of Texas Southwestern Medical Center
Collaborators:
Information provided by: University of Texas Southwestern Medical Center
Identifier: NCT00703209

Purpose

The UT Southwestern Medical Center at Dallas would like to give you information about a research study that is being done for patients with painful diabetic neuropathy and have not responded to medical treatment. Doctors from the departments of Internal Medicine, Physical Medicine and Rehabilitation, Neurology, Pain Management and Plastic Surgery are conducting a research study to examine the effects of nerve decompression on decreasing the pain associated with diabetic neuropathy and increasing the sensation at the bottom of the foot.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

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

Inclusion Criteria: - Type 1 or 2 Diabetes - Diagnosed with peripheral neuropathy - Symptoms of: pain and/or numbness - Bilateral symptoms (pain in both legs) - Have been treated non-surgically - Aged 18-80 - All genders and all races Exclusion Criteria: - Cardiac or renal pedal edema - Medical condition which does not allow surgery - Inadequate glycemic control - Skin ulcer - Charcot's foot - Symptoms of radiculopathy/sciatic-type nerve pain - Inadequate nutrient circulation in the feet - Weight greater than 300 lbs. - Psychiatric problems or alcohol/drug abuse - Pregnancy

Investigators

  • Investigator: Shai M Rozen, MD - Principal Investigator - UT Southwestern Medical Center at Dallas

Locations

  • UT Southwestern Medical Center

    Dallas, Texas 75390 United States

Conditions related to this trial:

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