Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression (DNND)
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| ClinicalTrials.gov Identifier: NCT00703209 |
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Recruitment Status :
Completed
First Posted : June 23, 2008
Last Update Posted : May 28, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Painful Diabetic Neuropathy | Procedure: Nerve Decompression | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 138 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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- 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 ]
- To measure changes in quality of life. This includes medication changes, pain relief, restoration of sensation, etc. [ Time Frame: 2 years ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703209
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: | Shai M Rozen, MD | UT Southwestern Medical Center at Dallas |
| Responsible Party: | Shai Michael Rozen, Associate Professor, Department of Plastic Surgery, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00703209 History of Changes |
| Other Study ID Numbers: |
UTSW-001 |
| First Posted: | June 23, 2008 Key Record Dates |
| Last Update Posted: | May 28, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Shai Michael Rozen, University of Texas Southwestern Medical Center:
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symptomatic diabetic neuropathy diabetes burning feet Diabetic Neuropathy |
Loss of sensation in the foot Neuropathy Painful Diabetic Neuropathy |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |