Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Dr. Shai Rozen, is working with physicians from Internal Medicine, Neurology, and Physical
      Medicine and Rehabilitation to conduct a clinical study on patients with painful diabetic
      neuropathy. Specifically, regarding the efficacy of peripheral nerve decompression in the
      lower extremity in a select group of patients which may have superimposed nerve compression
      in addition to their diabetic neuropathy. Initial data supports success rates at around 80%
      in terms of significant alleviation of pain and restoration of at least protective sensation
      and long term follow ups have suggested decrease in prevalence of infections, ulcerations,
      and amputations.

      Potential candidates for the study are patients who have symptomatic painful diabetic
      neuropathy who have not responded to medical treatment (glucose control, pain medications)and
      continue to have severe pain.

      It is thought today that one third of patients with diabetic neuropathy may have superimposed
      nerve compression in the nerves in the leg, or in other words the nerves may be pressed by
      the surrounding tissue. This nerve compression is what might be contributing to the pain, and
      often loss of sensation at the bottom of your feet. The principle is similar to carpal tunnel
      syndrome which is pressure of a nerve in the wrist. Carpal tunnel syndrome is seen in 14-30%
      of patients with diabetes compared to 2% in the general population.

      This study involves one year of close care and follow-up. As a part of this study, you will
      have regular evaluations by a foot care specialist from Physical Medicine and Rehabilitation,
      receive glucose management tips from a Diabetic Nurse Educator, and also have specialized,
      non-invasive testing in the Neurology department. The care that you would receive for being a
      part of this study is highly exceptional due to the various departments involved and their
      dedication to this research.

      Initial data supports success rates at around 80% in terms of significant alleviation of pain
      and restoration of at least protective sensation and long term follow ups have suggested
      decrease in prevalence of infections, ulcerations, and amputations.

      Potential candidates for the study are patients who have symptomatic painful diabetic
      neuropathy who have not responded to medical treatment (glucose control, pain medications)
      for at least one year and continue to have severe pain.

      Dr. Shai Rozen is the principal investigator on this study, and Julia Kalayanamit is the
      clinical coordinator. We are both very happy to speak with you if you would like more
      information about the study, including appointments, scheduling and visit activities.
    

Intervention name(s): Nerve Decompression
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: symptomatic diabetic neuropathy; diabetes; burning feet; Diabetic Neuropathy; Loss of sensation in the foot; Neuropathy; Painful Diabetic Neuropathy