Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression (DNND)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00703209
First received: June 19, 2008
Last updated: August 10, 2011
Last verified: August 2011
  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.


Condition Intervention
Painful Diabetic Neuropathy
Procedure: Nerve Decompression

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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To determine if nerve decompression of lower extremities in patients suffering from painful symptomatic diabetic neuropathy with chronic nerve compression, has a significant impact on alleviation of pain, and improvement in quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure changes in quality of life. This includes medication changes, pain relief, restoration of sensation, etc. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: January 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Procedure: Nerve Decompression
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.
No Intervention: 2
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00703209

Contacts
Contact: Julia Turner, RN, BS 214-645-3012 Julia.Turner@utsouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Julia Turner, BS, RN    214-645-3012    Julia.Turner@utsouthwestern.edu   
Contact: Debby Noble    214-648-8686    debby.noble@utsouthwestern.edu   
Principal Investigator: Shai M Rozen, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Shai M Rozen, MD UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: Shai M. Rozen, MD / Assistant Professor, UT Southwestern Medical Center at Dallas - Dept. of Plastic Surgery
ClinicalTrials.gov Identifier: NCT00703209     History of Changes
Other Study ID Numbers: UTSW-001
Study First Received: June 19, 2008
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
symptomatic diabetic neuropathy
diabetes
burning feet
Diabetes
Diabetic Neuropathy
Loss of sensation in the foot
Neuropathy
Painful Diabetic Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 22, 2014