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| Name | Class |
|---|---|
| Association of Extremity Nerve Surgeons | OTHER |
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The purpose of this study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Also, to monitor muscle strength, balance/gait and blood flow in the lower extremity before and after surgery.
Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A - Non-Diabetic, Gait and Balance | Procedure | Arm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University, and therefore do not include the inclusion/exclusion criterion that are specifically related to the blood flow assessment. Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet. |
| Measure | Description | Time Frame |
|---|---|---|
| EMG signals used intraoperative as objective measurements of change before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery | Primary Endpoint is assessed by changes in:
| Within one month of surgical date, surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sensory perception |
| up to one month of surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery. |
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Inclusion Criteria:
Exclusions Criteria:
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Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan L Fritz, D.C., M.S. | Contact | 479-531-6133 | megan.fritz.dc@gmail.com | |
| James C Anderson, DPM | Contact | 970-484-4620 | janderson@andersonpodiatrycenter.com |
| Name | Affiliation | Role |
|---|---|---|
| James C. Anderson, DPM | Anderson Podiatry Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Podiatry Center, Neuropathy Testing Center of Colorado | Recruiting | Fort Collins | Colorado | 80524 | United States |
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| ID | Term |
|---|---|
| D005684 | Gait |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016138 | Walking |
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| D008124 |
| Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |