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

NCT00703209 | Completed

• 1 other identifier: UTSW-001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Neuropathy

Keywords

symptomatic diabetic neuropathy; diabetes; burning feet; Diabetic Neuropathy; Loss of sensation in the foot; Neuropathy; Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• To measure changes in quality of life. This includes medication changes, pain relief, restoration of sensation, etc.

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

NO INTERVENTION

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.

Interventions

Nerve Decompression 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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shai M Rozen, MD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Plastic Surgery

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)