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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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The purpose of the study is to determine whether or not surgical decompression of the common peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral neuropathy is effective treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical decompression | Experimental | Surgical decompression of the common peroneal, tibial, and deep peroneal nerves |
|
| Standard medical care | No Intervention | Standard diabetic care and medical care provided for diabetic sensorimotor polyneuropathy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Surgical decompression of the common peroneal, tibial, and deep peroneal nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if lower extremity nerve decompression in patients suffering from symptomatic diabetic peripheral neuropathy significantly alleviates pain. | 0,3,6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Symptoms as measured by the Total Neuropathy Score (TNS) | 0,3,6, and 12 months | |
| Signs of peripheral neuropathy - two-point discriminations and pressure thresholds, vibration sensibility | 0 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J Best, MD, MSc | Northern Ontario School of Medicine | Principal Investigator |
| Sante Fratesi, MD, MSc | Northern Ontario School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sault Area Hospital | Sault Ste. Marie | Ontario | P6A 2C4 | Canada |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Nerve Conduction Velocity | 0 and 12 months |
| Quality of Life | 0,3,6, and 12 months |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |