Painful Diabetic NeuropathyDNNDNCT00703209
Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression
A study testing Nerve Decompression in people with Painful Diabetic Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Nerve Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Inadequate nutrient circulation in the feet
- Weight greater than 300 lbs.
- Psychiatric problems or alcohol/drug abuse
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Nerve Decompression
- Keywords
- symptomatic diabetic neuropathy, diabetes, burning feet, Diabetic Neuropathy, Loss of sensation in the foot, Neuropathy, Painful Diabetic Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve DecompressionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
To measure changes in quality of life. This includes medication changes, pain relief, restoration of sensation, etc.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shai Michael Rozen, University of Texas Southwestern Medical Center
- Investigators
- Shai M Rozen, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703209
- Sponsor's protocol ID
- UTSW-001
- Acronym
- DNND
- Status last verified
- May 2015
- First submitted
- 19 Jun 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00703209
- Acronym / sponsor ID
- DNND / UTSW-001
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- symptomatic diabetic neuropathy, diabetes, burning feet, Diabetic Neuropathy, Loss of sensation in the foot, Neuropathy, Painful Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Nerve DecompressionPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Cardiac or renal pedal edema
- Medical condition which does not allow surgery
- Inadequate glycemic control
- Skin ulcer
- Charcot's foot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve DecompressionNerve 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. | Procedure or surgery | 1 |
Primary outcome
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
1 secondary outcome
To measure changes in quality of life. This includes medication changes, pain relief, restoration of sensation, etc.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai M Rozen, MD principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Decompression in people with Painful Diabetic Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.