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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
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Patients who are randomized to receive surgical care, will receive the nerve decompression, along with similar incisions on the opposite leg, but no decompression on that leg. This will serve as the patient's control leg, and also blind them to the treatment leg.
Subjects who are not randomized to receive the surgical procedure will be followed up with the same clinic visits as the patients who are receiving the surgical procedure.
Nerve decompression on a randomized leg, with similar skin incisions on the opposite leg so that the patient is "blinded" to which leg received the decompression.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
- 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
- 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
- Investigator: Shai M Rozen, MD - Principal Investigator - UT Southwestern Medical Center at Dallas